No significant difference in rate of death was found in patients who underwent either bilateral or single internal thoracic artery grafting during coronary artery bypass grafting (CABG) surgery, according to a randomized trial of patients who were scheduled to undergo CABG.

“At 10 years, in intention-to-treat analyses, there were no significant between-group differences in all-cause mortality,” wrote lead author David P. Taggart, MD, PhD, of the University of Oxford (England), and his coauthors, adding that “the results of this trial are not consistent with data from previous, nonrandomized studies.” The study was published in the New England Journal of Medicine.

In the multicenter, unblinded Arterial Revascularization Trial (ART), 3,102 patients with multivessel coronary artery disease were divided into two groups: the bilateral-graft group (1,548 patients) and the single-graft group (1,554). They were assigned to receive bilateral internal thoracic artery grafts or a standard single left internal thoracic artery graft during CABG, respectively. However, 13.9% of the patients in the bilateral-graft group received only a single internal thoracic artery graft, while 21.8% of those in the single-graft group also received a radial artery graft.


At 10-year follow-up, 644 patients (20.8%) had died; 315 deaths (20.3%) occurred in the bilateral-graft group and 329 (21.2%) occurred in the single-graft group. A total of 385 patients (24.9%) suffered MI, stroke, or death in the bilateral-graft group, compared with 425 (27.3%) in the single-graft group (hazard ratio, 0.90; 95% confidence interval, 0.79-1.03).

The coauthors noted several reasons that the results of their trial may not have matched previous data, including conflicting evidence about vein graft failure’s clinical effect on survival and the aforementioned patients who were assigned to a specific group but received alternate grafting. In addition, they acknowledged that ART was an unblinded trial and “biases may be introduced in the treatment of patients, depending on their randomization assignment.”

The study was supported by grants from the British Heart Foundation, the U.K. Medical Research Council, and the National Institute of Health Research Efficacy and Mechanistic Evaluation Program. No relevant conflicts of interest were reported.

SOURCE: Taggart DP et al. N Engl J Med. 2019 Jan 31. doi: 10.1056/NEJMoa1808783.

No significant difference in rate of death was found in patients who underwent either bilateral or single internal thoracic artery grafting during coronary artery bypass grafting (CABG) surgery, according to a randomized trial of patients who were scheduled to undergo CABG.

“At 10 years, in intention-to-treat analyses, there were no significant between-group differences in all-cause mortality,” wrote lead author David P. Taggart, MD, PhD, of the University of Oxford (England), and his coauthors, adding that “the results of this trial are not consistent with data from previous, nonrandomized studies.” The study was published in the New England Journal of Medicine.

In the multicenter, unblinded Arterial Revascularization Trial (ART), 3,102 patients with multivessel coronary artery disease were divided into two groups: the bilateral-graft group (1,548 patients) and the single-graft group (1,554). They were assigned to receive bilateral internal thoracic artery grafts or a standard single left internal thoracic artery graft during CABG, respectively. However, 13.9% of the patients in the bilateral-graft group received only a single internal thoracic artery graft, while 21.8% of those in the single-graft group also received a radial artery graft.


At 10-year follow-up, 644 patients (20.8%) had died; 315 deaths (20.3%) occurred in the bilateral-graft group and 329 (21.2%) occurred in the single-graft group. A total of 385 patients (24.9%) suffered MI, stroke, or death in the bilateral-graft group, compared with 425 (27.3%) in the single-graft group (hazard ratio, 0.90; 95% confidence interval, 0.79-1.03).

The coauthors noted several reasons that the results of their trial may not have matched previous data, including conflicting evidence about vein graft failure’s clinical effect on survival and the aforementioned patients who were assigned to a specific group but received alternate grafting. In addition, they acknowledged that ART was an unblinded trial and “biases may be introduced in the treatment of patients, depending on their randomization assignment.”

The study was supported by grants from the British Heart Foundation, the U.K. Medical Research Council, and the National Institute of Health Research Efficacy and Mechanistic Evaluation Program. No relevant conflicts of interest were reported.

SOURCE: Taggart DP et al. N Engl J Med. 2019 Jan 31. doi: 10.1056/NEJMoa1808783.

No significant difference in rate of death was found in patients who underwent either bilateral or single internal thoracic artery grafting during coronary artery bypass grafting (CABG) surgery, according to a randomized trial of patients who were scheduled to undergo CABG.

“At 10 years, in intention-to-treat analyses, there were no significant between-group differences in all-cause mortality,” wrote lead author David P. Taggart, MD, PhD, of the University of Oxford (England), and his coauthors, adding that “the results of this trial are not consistent with data from previous, nonrandomized studies.” The study was published in the New England Journal of Medicine.

In the multicenter, unblinded Arterial Revascularization Trial (ART), 3,102 patients with multivessel coronary artery disease were divided into two groups: the bilateral-graft group (1,548 patients) and the single-graft group (1,554). They were assigned to receive bilateral internal thoracic artery grafts or a standard single left internal thoracic artery graft during CABG, respectively. However, 13.9% of the patients in the bilateral-graft group received only a single internal thoracic artery graft, while 21.8% of those in the single-graft group also received a radial artery graft.


At 10-year follow-up, 644 patients (20.8%) had died; 315 deaths (20.3%) occurred in the bilateral-graft group and 329 (21.2%) occurred in the single-graft group. A total of 385 patients (24.9%) suffered MI, stroke, or death in the bilateral-graft group, compared with 425 (27.3%) in the single-graft group (hazard ratio, 0.90; 95% confidence interval, 0.79-1.03).

The coauthors noted several reasons that the results of their trial may not have matched previous data, including conflicting evidence about vein graft failure’s clinical effect on survival and the aforementioned patients who were assigned to a specific group but received alternate grafting. In addition, they acknowledged that ART was an unblinded trial and “biases may be introduced in the treatment of patients, depending on their randomization assignment.”

The study was supported by grants from the British Heart Foundation, the U.K. Medical Research Council, and the National Institute of Health Research Efficacy and Mechanistic Evaluation Program. No relevant conflicts of interest were reported.

SOURCE: Taggart DP et al. N Engl J Med. 2019 Jan 31. doi: 10.1056/NEJMoa1808783.

If you live in Spokane, Wash., 99213 and 99214 are important numbers. Interchanging the last two digits can send your mail into the Twilight Zone. Otherwise those five digit sequences have little significance to most Americans ... unless of course you are a physician. You have been told multiple times by practice administrators and business consultants that the failure to attach the proper sequence to your bill for services can threaten the sustainability of your practice’s bottom line or put you at risk for a costly fine.

utah778/Thinkstock

Numerical codes for office visits were not handed down on stone tablets. There was a time when a physician simply charged for something he called an “office visit” and about half that for a “short” office visit that took less time and probably nothing for a “quick recheck.” He chose the fees based on what he felt was reasonable. I remember reading of one physician who pegged his charges at a dollar per penny of the cost of a regular postage stamp. For a variety of obvious and some unfortunate reasons, these loosely structured fee structures have disappeared.

Now a physician is asked to justify his or her charges by documenting what transpired during the office visit. The patient always has been the best witness, and at least has some sense of how much work the physician has had to do to arrive at diagnosis and suggest a treatment plan. Because the patient usually was paying the bill and had a personal stake in the value of the services provided, this system seemed to make sense.

However, now some large corporate entity or government agency probably is paying the bill and would like some idea of what it is being billed for. Justifying the service provided now falls on the physician. When the billing codes were first introduced and before the payers became more curious, it was easy. I simply applied 99213 to all my office visits and once or twice a day I would code out a visit that seemed more complex as a 99214. I wasn’t keeping track of how many minutes I spent in each visit, how many questions I asked, or how many body parts I examined. Except for patients with injured extremities, everyone was pretty much getting the same exam. My coding was based on my perception of value and effort. If it took more time than usual to remove a bit of cerumen or reassure an unusually concerned parent I chalked that up as my misfortune, not a reason to code the visit as a 99214. If I felt I needed more money, I assumed that my best option was to see more patients. Neither the patients nor the payers seemed to be complaining.

But obviously somewhere someone felt that there were too many providers gaming the system and there needed to be a better way to assign value to what a physician was doing in his or her examining room. Not surprisingly, the current coding system is flawed. I don’t have a workable alternative. However, I always have felt that if the folks who were paying the bills would come visit my office (unannounced if they wish) and spend a morning watching me see patients, they could more accurately assign a value to my work. I’m not sure how many of you would be comfortable with that degree of transparency. But for me it would be worth it if it freed me from the burden of coding to justify my effort.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

If you live in Spokane, Wash., 99213 and 99214 are important numbers. Interchanging the last two digits can send your mail into the Twilight Zone. Otherwise those five digit sequences have little significance to most Americans ... unless of course you are a physician. You have been told multiple times by practice administrators and business consultants that the failure to attach the proper sequence to your bill for services can threaten the sustainability of your practice’s bottom line or put you at risk for a costly fine.

utah778/Thinkstock

Numerical codes for office visits were not handed down on stone tablets. There was a time when a physician simply charged for something he called an “office visit” and about half that for a “short” office visit that took less time and probably nothing for a “quick recheck.” He chose the fees based on what he felt was reasonable. I remember reading of one physician who pegged his charges at a dollar per penny of the cost of a regular postage stamp. For a variety of obvious and some unfortunate reasons, these loosely structured fee structures have disappeared.

Now a physician is asked to justify his or her charges by documenting what transpired during the office visit. The patient always has been the best witness, and at least has some sense of how much work the physician has had to do to arrive at diagnosis and suggest a treatment plan. Because the patient usually was paying the bill and had a personal stake in the value of the services provided, this system seemed to make sense.

However, now some large corporate entity or government agency probably is paying the bill and would like some idea of what it is being billed for. Justifying the service provided now falls on the physician. When the billing codes were first introduced and before the payers became more curious, it was easy. I simply applied 99213 to all my office visits and once or twice a day I would code out a visit that seemed more complex as a 99214. I wasn’t keeping track of how many minutes I spent in each visit, how many questions I asked, or how many body parts I examined. Except for patients with injured extremities, everyone was pretty much getting the same exam. My coding was based on my perception of value and effort. If it took more time than usual to remove a bit of cerumen or reassure an unusually concerned parent I chalked that up as my misfortune, not a reason to code the visit as a 99214. If I felt I needed more money, I assumed that my best option was to see more patients. Neither the patients nor the payers seemed to be complaining.

But obviously somewhere someone felt that there were too many providers gaming the system and there needed to be a better way to assign value to what a physician was doing in his or her examining room. Not surprisingly, the current coding system is flawed. I don’t have a workable alternative. However, I always have felt that if the folks who were paying the bills would come visit my office (unannounced if they wish) and spend a morning watching me see patients, they could more accurately assign a value to my work. I’m not sure how many of you would be comfortable with that degree of transparency. But for me it would be worth it if it freed me from the burden of coding to justify my effort.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

If you live in Spokane, Wash., 99213 and 99214 are important numbers. Interchanging the last two digits can send your mail into the Twilight Zone. Otherwise those five digit sequences have little significance to most Americans ... unless of course you are a physician. You have been told multiple times by practice administrators and business consultants that the failure to attach the proper sequence to your bill for services can threaten the sustainability of your practice’s bottom line or put you at risk for a costly fine.

utah778/Thinkstock

Numerical codes for office visits were not handed down on stone tablets. There was a time when a physician simply charged for something he called an “office visit” and about half that for a “short” office visit that took less time and probably nothing for a “quick recheck.” He chose the fees based on what he felt was reasonable. I remember reading of one physician who pegged his charges at a dollar per penny of the cost of a regular postage stamp. For a variety of obvious and some unfortunate reasons, these loosely structured fee structures have disappeared.

Now a physician is asked to justify his or her charges by documenting what transpired during the office visit. The patient always has been the best witness, and at least has some sense of how much work the physician has had to do to arrive at diagnosis and suggest a treatment plan. Because the patient usually was paying the bill and had a personal stake in the value of the services provided, this system seemed to make sense.

However, now some large corporate entity or government agency probably is paying the bill and would like some idea of what it is being billed for. Justifying the service provided now falls on the physician. When the billing codes were first introduced and before the payers became more curious, it was easy. I simply applied 99213 to all my office visits and once or twice a day I would code out a visit that seemed more complex as a 99214. I wasn’t keeping track of how many minutes I spent in each visit, how many questions I asked, or how many body parts I examined. Except for patients with injured extremities, everyone was pretty much getting the same exam. My coding was based on my perception of value and effort. If it took more time than usual to remove a bit of cerumen or reassure an unusually concerned parent I chalked that up as my misfortune, not a reason to code the visit as a 99214. If I felt I needed more money, I assumed that my best option was to see more patients. Neither the patients nor the payers seemed to be complaining.

But obviously somewhere someone felt that there were too many providers gaming the system and there needed to be a better way to assign value to what a physician was doing in his or her examining room. Not surprisingly, the current coding system is flawed. I don’t have a workable alternative. However, I always have felt that if the folks who were paying the bills would come visit my office (unannounced if they wish) and spend a morning watching me see patients, they could more accurately assign a value to my work. I’m not sure how many of you would be comfortable with that degree of transparency. But for me it would be worth it if it freed me from the burden of coding to justify my effort.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

CORONADO, CALIF. – Mild obstructive sleep apnea (OSA) resolves in about one-third of children younger than age 3 years after an observation period of 3-12 months, results from a single-center study showed.

“OSA affects up to 6% of the pediatric population, and diagnosis of young children can be particularly challenging due to the heterogeneity of presenting symptoms,” Douglas C. von Allmen, MD, said at the Triological Society’s Combined Sections Meeting. “While school-age children may present with snoring, that’s less common in the younger population. Up to one-quarter of infants may have noisy breathing, which may mimic obstructive events throughout the first 3 years of life. Additionally, long-term clinical implications of mild sleep apnea in very young children is unclear.”

According to Dr. von Allmen, a fifth-year otolaryngology resident at the University of Cincinnati, management strategies of children with OSA can include a period of observation, particularly when there’s an absence of concerning findings on polysomnography (PSG), such as hypoventilation or significant hypoxia, or when the primary etiology of the OSA is unknown. “Additionally, few studies at this point have attempted to characterize the natural history of mild OSA in pediatric patients under 3 years of age,” he said.

In an effort to assess the effects of observation on the PSG outcomes of children under 3 years with mild OSA, Dr. Von Allmen and his colleagues performed a retrospective review of 26 children who had an overnight PSG with a follow-up PSG performed 3-12 months later. They excluded patients with neuromuscular disease, tracheostomy, or interstitial lung disease. All PSGs were performed at the Cincinnati Children’s Hospital Medical Center between 2012 and 2017 and were scored by a board-certified sleep physician. The researchers defined mild OSA as at least one, but fewer than five, events per hour. The mean age of the 26 patients was 7 months, 65% were male, 92% were white, and their median body mass index was in the 39th percentile. Comorbidities include laryngomalacia (40%), cardiac disease (40%), allergies (34%), asthma (23%), and Down syndrome (11%).

Between baseline and follow-up, the apnea-hypoapnea index (AHI) trended downward from 4.3 to 3.4 events per hour (P = .19), the obstructive AHI decreased significantly from 2.7 to 1.3 events per hour (P = .013), while the central apnea index also trended downward from 1.4 to 1.2 events per hour (P = .60). The oxyhemoglobin nadir and sleep efficiency did not change significantly, but there was a decrease in the arousal index (from 14.7 to 13 events per hour; P = .027) and in the percentage of REM sleep (from 33% to 30%; P = .008).

As for postobservation OSA severity outcomes, eight patients (31%) resolved spontaneously, one patient progressed from mild to moderate OSA, and the rest remained in their mild OSA state. Subanalysis revealed that OSA resolution rate was 36% in patients with laryngomalacia, compared with 27% in those with no laryngomalacia, a difference that did not reach statistical significance (P = .98).

Dr. von Allmen pointed out that the study cohort had comorbidities which may have contributed to the persistence of OSA. He also acknowledged certain limitations of the study, including its retrospective nature, the potential for selection bias, the small sample size, and the fact that it did not include a control sample of normal children. “The presence of laryngomalacia did not affect the resolution rate in our cohort, but we’ll need larger studies to better elucidate the factors that do affect persistent disease and to identify the optimal timing of intervention in children with mild OSA,” he said.

Dr. von Allmen reported having no financial disclosures. The study received a resident research award at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: von Allmen DC et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Mild obstructive sleep apnea (OSA) resolves in about one-third of children younger than age 3 years after an observation period of 3-12 months, results from a single-center study showed.

“OSA affects up to 6% of the pediatric population, and diagnosis of young children can be particularly challenging due to the heterogeneity of presenting symptoms,” Douglas C. von Allmen, MD, said at the Triological Society’s Combined Sections Meeting. “While school-age children may present with snoring, that’s less common in the younger population. Up to one-quarter of infants may have noisy breathing, which may mimic obstructive events throughout the first 3 years of life. Additionally, long-term clinical implications of mild sleep apnea in very young children is unclear.”

According to Dr. von Allmen, a fifth-year otolaryngology resident at the University of Cincinnati, management strategies of children with OSA can include a period of observation, particularly when there’s an absence of concerning findings on polysomnography (PSG), such as hypoventilation or significant hypoxia, or when the primary etiology of the OSA is unknown. “Additionally, few studies at this point have attempted to characterize the natural history of mild OSA in pediatric patients under 3 years of age,” he said.

In an effort to assess the effects of observation on the PSG outcomes of children under 3 years with mild OSA, Dr. Von Allmen and his colleagues performed a retrospective review of 26 children who had an overnight PSG with a follow-up PSG performed 3-12 months later. They excluded patients with neuromuscular disease, tracheostomy, or interstitial lung disease. All PSGs were performed at the Cincinnati Children’s Hospital Medical Center between 2012 and 2017 and were scored by a board-certified sleep physician. The researchers defined mild OSA as at least one, but fewer than five, events per hour. The mean age of the 26 patients was 7 months, 65% were male, 92% were white, and their median body mass index was in the 39th percentile. Comorbidities include laryngomalacia (40%), cardiac disease (40%), allergies (34%), asthma (23%), and Down syndrome (11%).

Between baseline and follow-up, the apnea-hypoapnea index (AHI) trended downward from 4.3 to 3.4 events per hour (P = .19), the obstructive AHI decreased significantly from 2.7 to 1.3 events per hour (P = .013), while the central apnea index also trended downward from 1.4 to 1.2 events per hour (P = .60). The oxyhemoglobin nadir and sleep efficiency did not change significantly, but there was a decrease in the arousal index (from 14.7 to 13 events per hour; P = .027) and in the percentage of REM sleep (from 33% to 30%; P = .008).

As for postobservation OSA severity outcomes, eight patients (31%) resolved spontaneously, one patient progressed from mild to moderate OSA, and the rest remained in their mild OSA state. Subanalysis revealed that OSA resolution rate was 36% in patients with laryngomalacia, compared with 27% in those with no laryngomalacia, a difference that did not reach statistical significance (P = .98).

Dr. von Allmen pointed out that the study cohort had comorbidities which may have contributed to the persistence of OSA. He also acknowledged certain limitations of the study, including its retrospective nature, the potential for selection bias, the small sample size, and the fact that it did not include a control sample of normal children. “The presence of laryngomalacia did not affect the resolution rate in our cohort, but we’ll need larger studies to better elucidate the factors that do affect persistent disease and to identify the optimal timing of intervention in children with mild OSA,” he said.

Dr. von Allmen reported having no financial disclosures. The study received a resident research award at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: von Allmen DC et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Mild obstructive sleep apnea (OSA) resolves in about one-third of children younger than age 3 years after an observation period of 3-12 months, results from a single-center study showed.

“OSA affects up to 6% of the pediatric population, and diagnosis of young children can be particularly challenging due to the heterogeneity of presenting symptoms,” Douglas C. von Allmen, MD, said at the Triological Society’s Combined Sections Meeting. “While school-age children may present with snoring, that’s less common in the younger population. Up to one-quarter of infants may have noisy breathing, which may mimic obstructive events throughout the first 3 years of life. Additionally, long-term clinical implications of mild sleep apnea in very young children is unclear.”

According to Dr. von Allmen, a fifth-year otolaryngology resident at the University of Cincinnati, management strategies of children with OSA can include a period of observation, particularly when there’s an absence of concerning findings on polysomnography (PSG), such as hypoventilation or significant hypoxia, or when the primary etiology of the OSA is unknown. “Additionally, few studies at this point have attempted to characterize the natural history of mild OSA in pediatric patients under 3 years of age,” he said.

In an effort to assess the effects of observation on the PSG outcomes of children under 3 years with mild OSA, Dr. Von Allmen and his colleagues performed a retrospective review of 26 children who had an overnight PSG with a follow-up PSG performed 3-12 months later. They excluded patients with neuromuscular disease, tracheostomy, or interstitial lung disease. All PSGs were performed at the Cincinnati Children’s Hospital Medical Center between 2012 and 2017 and were scored by a board-certified sleep physician. The researchers defined mild OSA as at least one, but fewer than five, events per hour. The mean age of the 26 patients was 7 months, 65% were male, 92% were white, and their median body mass index was in the 39th percentile. Comorbidities include laryngomalacia (40%), cardiac disease (40%), allergies (34%), asthma (23%), and Down syndrome (11%).

Between baseline and follow-up, the apnea-hypoapnea index (AHI) trended downward from 4.3 to 3.4 events per hour (P = .19), the obstructive AHI decreased significantly from 2.7 to 1.3 events per hour (P = .013), while the central apnea index also trended downward from 1.4 to 1.2 events per hour (P = .60). The oxyhemoglobin nadir and sleep efficiency did not change significantly, but there was a decrease in the arousal index (from 14.7 to 13 events per hour; P = .027) and in the percentage of REM sleep (from 33% to 30%; P = .008).

As for postobservation OSA severity outcomes, eight patients (31%) resolved spontaneously, one patient progressed from mild to moderate OSA, and the rest remained in their mild OSA state. Subanalysis revealed that OSA resolution rate was 36% in patients with laryngomalacia, compared with 27% in those with no laryngomalacia, a difference that did not reach statistical significance (P = .98).

Dr. von Allmen pointed out that the study cohort had comorbidities which may have contributed to the persistence of OSA. He also acknowledged certain limitations of the study, including its retrospective nature, the potential for selection bias, the small sample size, and the fact that it did not include a control sample of normal children. “The presence of laryngomalacia did not affect the resolution rate in our cohort, but we’ll need larger studies to better elucidate the factors that do affect persistent disease and to identify the optimal timing of intervention in children with mild OSA,” he said.

Dr. von Allmen reported having no financial disclosures. The study received a resident research award at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: von Allmen DC et al. Triological CSM, Abstracts.

A new instrument for measuring disease activity in systemic lupus erythematosus had better performance than that of the current most widely-used measure, according to investigators.

enot-poloskun/iStock/Getty Images Plus

In terms of identifying clinically significant changes, the Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) was superior to the SLE Disease Activity Index 2000 (SLEDAI-2K), said the authors of a longitudinal cohort study comparing the two instruments.

The SLE-DAS maintained high specificity compared with the SLEDAI-2K and had a similar clinical workup time requirement, according to Diogo Jesus, MD, of the rheumatology department at Centro Hospitalar e Universitário de Coimbra, Portugal, and his colleagues.

“Such a performance can have major implications in the interpretation of clinical trials applying the disease activity as the primary endpoint, and in daily clinical practice, where SLE-DAS could provide robust guidance for treatment in the individual patient,” Dr. Jesus and his coauthors wrote in Annals of the Rheumatic Diseases.

The longitudinal cohort study by Dr. Jesus and his colleagues included 520 patients with SLE from tertiary care centers in Coimbra, Portugal, and Padova, Italy. These included a derivation cohort of 324 patients and an external validation cohort of 196 patients (the Padova Lupus Cohort).

A cutoff value of 1.72 for change in the 17-item SLE-DAS had significantly higher sensitivities to detect a clinical meaningful improvement in both the derivation (82.1%) and external validation (89.5%) cohorts, compared with a cutoff value of 4 or higher in the SLEDAI-2K at 44.8% and 47.4%, respectively, the investigators reported. Likewise, ability to detect clinically meaningful worsening was significantly higher with SLE-DAS, with sensitivities of 93.1% in the derivation cohort and 95.5% in the external validation group versus a respective 46.6% and 59.1% for SLEDAI-2K. Both clinical improvement and worsening were defined by a change in the Physician Global Assessment score of 0.3 or more.

Specificity was high for both instruments, with values around 98%-99% in both cohorts for clinically meaningful worsening and about 97%-100% for clinically meaningful improvement, the report shows.

Further analyses showed that disease activity tracked over time with SLE-DAS had a higher predictive value for damage accrual versus the SLEDAI-2K, according to the investigators.

The SLE-DAS formula, published in the journal by Dr. Jesus and his colleagues, includes a total of 17 weighted and mostly binary variables: presence or absence of alopecia, arthritis, cardiac/pulmonary involvement, generalized cutaneous rash, hemolytic anemia, hypocomplementemia, increased anti-dsDNA levels, leukopenia, localized cutaneous rash, mucocutaneous vasculitis, mucosal ulcers, myositis, neuropsychiatric involvement, proteinuria, serositis, systemic vasculitis, and thrombocytopenia.

Next, the researchers plan to define SLE-DAS cutoff values for remission, low disease activity, and moderate or high disease activity. An online calculator is also in the works, they said.

Dr. Jesus and his coauthors did not report any outside funding for the study and said they had no competing interests related to their research.

SOURCE: Jesus D et al. Ann Rheum Dis. 2019 Jan 9. doi: 10.1136/annrheumdis-2018-214502.

A new instrument for measuring disease activity in systemic lupus erythematosus had better performance than that of the current most widely-used measure, according to investigators.

enot-poloskun/iStock/Getty Images Plus

In terms of identifying clinically significant changes, the Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) was superior to the SLE Disease Activity Index 2000 (SLEDAI-2K), said the authors of a longitudinal cohort study comparing the two instruments.

The SLE-DAS maintained high specificity compared with the SLEDAI-2K and had a similar clinical workup time requirement, according to Diogo Jesus, MD, of the rheumatology department at Centro Hospitalar e Universitário de Coimbra, Portugal, and his colleagues.

“Such a performance can have major implications in the interpretation of clinical trials applying the disease activity as the primary endpoint, and in daily clinical practice, where SLE-DAS could provide robust guidance for treatment in the individual patient,” Dr. Jesus and his coauthors wrote in Annals of the Rheumatic Diseases.

The longitudinal cohort study by Dr. Jesus and his colleagues included 520 patients with SLE from tertiary care centers in Coimbra, Portugal, and Padova, Italy. These included a derivation cohort of 324 patients and an external validation cohort of 196 patients (the Padova Lupus Cohort).

A cutoff value of 1.72 for change in the 17-item SLE-DAS had significantly higher sensitivities to detect a clinical meaningful improvement in both the derivation (82.1%) and external validation (89.5%) cohorts, compared with a cutoff value of 4 or higher in the SLEDAI-2K at 44.8% and 47.4%, respectively, the investigators reported. Likewise, ability to detect clinically meaningful worsening was significantly higher with SLE-DAS, with sensitivities of 93.1% in the derivation cohort and 95.5% in the external validation group versus a respective 46.6% and 59.1% for SLEDAI-2K. Both clinical improvement and worsening were defined by a change in the Physician Global Assessment score of 0.3 or more.

Specificity was high for both instruments, with values around 98%-99% in both cohorts for clinically meaningful worsening and about 97%-100% for clinically meaningful improvement, the report shows.

Further analyses showed that disease activity tracked over time with SLE-DAS had a higher predictive value for damage accrual versus the SLEDAI-2K, according to the investigators.

The SLE-DAS formula, published in the journal by Dr. Jesus and his colleagues, includes a total of 17 weighted and mostly binary variables: presence or absence of alopecia, arthritis, cardiac/pulmonary involvement, generalized cutaneous rash, hemolytic anemia, hypocomplementemia, increased anti-dsDNA levels, leukopenia, localized cutaneous rash, mucocutaneous vasculitis, mucosal ulcers, myositis, neuropsychiatric involvement, proteinuria, serositis, systemic vasculitis, and thrombocytopenia.

Next, the researchers plan to define SLE-DAS cutoff values for remission, low disease activity, and moderate or high disease activity. An online calculator is also in the works, they said.

Dr. Jesus and his coauthors did not report any outside funding for the study and said they had no competing interests related to their research.

SOURCE: Jesus D et al. Ann Rheum Dis. 2019 Jan 9. doi: 10.1136/annrheumdis-2018-214502.

A new instrument for measuring disease activity in systemic lupus erythematosus had better performance than that of the current most widely-used measure, according to investigators.

enot-poloskun/iStock/Getty Images Plus

In terms of identifying clinically significant changes, the Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) was superior to the SLE Disease Activity Index 2000 (SLEDAI-2K), said the authors of a longitudinal cohort study comparing the two instruments.

The SLE-DAS maintained high specificity compared with the SLEDAI-2K and had a similar clinical workup time requirement, according to Diogo Jesus, MD, of the rheumatology department at Centro Hospitalar e Universitário de Coimbra, Portugal, and his colleagues.

“Such a performance can have major implications in the interpretation of clinical trials applying the disease activity as the primary endpoint, and in daily clinical practice, where SLE-DAS could provide robust guidance for treatment in the individual patient,” Dr. Jesus and his coauthors wrote in Annals of the Rheumatic Diseases.

The longitudinal cohort study by Dr. Jesus and his colleagues included 520 patients with SLE from tertiary care centers in Coimbra, Portugal, and Padova, Italy. These included a derivation cohort of 324 patients and an external validation cohort of 196 patients (the Padova Lupus Cohort).

A cutoff value of 1.72 for change in the 17-item SLE-DAS had significantly higher sensitivities to detect a clinical meaningful improvement in both the derivation (82.1%) and external validation (89.5%) cohorts, compared with a cutoff value of 4 or higher in the SLEDAI-2K at 44.8% and 47.4%, respectively, the investigators reported. Likewise, ability to detect clinically meaningful worsening was significantly higher with SLE-DAS, with sensitivities of 93.1% in the derivation cohort and 95.5% in the external validation group versus a respective 46.6% and 59.1% for SLEDAI-2K. Both clinical improvement and worsening were defined by a change in the Physician Global Assessment score of 0.3 or more.

Specificity was high for both instruments, with values around 98%-99% in both cohorts for clinically meaningful worsening and about 97%-100% for clinically meaningful improvement, the report shows.

Further analyses showed that disease activity tracked over time with SLE-DAS had a higher predictive value for damage accrual versus the SLEDAI-2K, according to the investigators.

The SLE-DAS formula, published in the journal by Dr. Jesus and his colleagues, includes a total of 17 weighted and mostly binary variables: presence or absence of alopecia, arthritis, cardiac/pulmonary involvement, generalized cutaneous rash, hemolytic anemia, hypocomplementemia, increased anti-dsDNA levels, leukopenia, localized cutaneous rash, mucocutaneous vasculitis, mucosal ulcers, myositis, neuropsychiatric involvement, proteinuria, serositis, systemic vasculitis, and thrombocytopenia.

Next, the researchers plan to define SLE-DAS cutoff values for remission, low disease activity, and moderate or high disease activity. An online calculator is also in the works, they said.

Dr. Jesus and his coauthors did not report any outside funding for the study and said they had no competing interests related to their research.

SOURCE: Jesus D et al. Ann Rheum Dis. 2019 Jan 9. doi: 10.1136/annrheumdis-2018-214502.

After a disappointing interim analysis, Roche and its collaborator AC Immune are halting two phase 3 trials of the antiamyloid antibody crenezumab.

CREAD 1 and CREAD 2 enrolled patients with prodromal-to-mild sporadic Alzheimer’s disease. The preplanned interim safety and efficacy analysis determined that neither study was likely to meet the primary endpoint of change from baseline on the Clinical Dementia Rating-sum of boxes score.

There were no unexpected safety signals associated with the drug, despite a quadrupling of the phase 3 dose from that used in phase 2. The company in its press release said that it will continue to conduct the Autosomal Dominant Alzheimer’s Disease (ADAD) trial as part of the Alzheimer’s Prevention Initiative (API). ADAD is a large South American trial of crenezumab in Colombian families with familial Alzheimer’s caused by mutations in the presenilin-1 gene (PSEN1).

Roche did not release any data but said the trial results will be discussed at an upcoming scientific meeting.

“While the results with crenezumab are disappointing, they meaningfully contribute to our understanding of Alzheimer’s disease,” Sandra Horning, MD, Roche’s chief medical officer and executive vice president for global development, said in an interview. “We gratefully acknowledge the participants in the CREAD trials and the efforts of everyone involved in this important program.”

The decision was not a surprise to researchers who have followed the antibody’s development. It advanced into phase 3 with lackluster phase 2 cognitive, imaging, and biomarker data. Its selection as the therapeutic agent for the ADAD trial was a key driver in its continued development, securing Roche $100 million in federal funds to help launch ADAD, the first-ever Alzheimer’s primary prevention study.

Despite its failure in sporadic Alzheimer’s, there is still some hope that crenezumab might benefit people with the PSEN1 mutation, said Richard Caselli, MD, professor of neurology at the Mayo Clinic Arizona in Scottsdale and associate director and clinical core director of the Arizona Alzheimer’s Disease Center.

“The Colombian trial is aimed at dominantly-inherited AD due to a PSEN1 mutation, so it is different enough to imagine it still might make a difference in patients in whom amyloid metabolism is actually defective due to functionally altered amyloid precursor protein or gamma secretase,” he said in an interview. “Possibly some might argue that many of the patients in the crenezumab trial likely had additional pathologies so that even if the AD component responded, the overall clinical picture might not reflect it due to the other components. That would be interesting if proven and could even argue against equating young-onset with late-onset AD, at least for clinical purposes, as is currently envisioned.”

Michael Wolfe, PhD, had a different take on the matter.

“Although amyloid-beta [Abeta] production is not necessarily altered in sporadic AD, there is essentially the same pathology, presentation, and progression with familial and sporadic AD, suggesting a common molecular mechanism,” said Dr. Wolfe, who is the Mathias P. Mertes Professor of Medicinal Chemistry at the University of Kansas, Lawrence. “It’s hard to say Abeta is the pathogenic species in familial but not sporadic AD.

The antibodies that have been failing for 5 years now were designed in the early 2000s, Dr. Kupiec pointed out, when knowledge of the various amyloid species was still immature. Newer candidates can target specific conformations of the protein – monomers and oligomers – before they aggregate into insoluble sheets. “Solanezumab was the first of these, paving the way for this new generation of antibodies,” Dr. Kupiec said.

Because they target soluble Abeta, not amyloid plaques, these domain-specific antibodies are less likely to elicit ARIA (amyloid-related imaging abnormalities), the inflammatory reaction that’s been associated with plaque dissolution in other antibody trials. ARIA has been a dose-limiting step for antiamyloid antibodies – one that conformationally targeted antibodies could avoid, Dr. Kupiec said.

“There may be some limited success with the these, and there may be enough of a treatment effect to secure approval,” he said. “The question is: Can we generate a higher effect size with an antibody that is more selective to the toxic forms of Abeta?”

PMN310 is ProMIS’ attempt to thread this needle. In preclinical studies, the antibody did not bind to amyloid monomers, plaques, or vascular Abeta aggregates. The company expects to take this antibody into phase 1 trials later this year.

“If we have a molecule that doesn’t bind to monomers or to plaques, but only to the toxic oligomer, then that is an something well worth testing in the clinic,” he said.

Dr. Caselli and Dr. Wolfe have no financial disclosures.

msullivan@mdedge.com

After a disappointing interim analysis, Roche and its collaborator AC Immune are halting two phase 3 trials of the antiamyloid antibody crenezumab.

CREAD 1 and CREAD 2 enrolled patients with prodromal-to-mild sporadic Alzheimer’s disease. The preplanned interim safety and efficacy analysis determined that neither study was likely to meet the primary endpoint of change from baseline on the Clinical Dementia Rating-sum of boxes score.

There were no unexpected safety signals associated with the drug, despite a quadrupling of the phase 3 dose from that used in phase 2. The company in its press release said that it will continue to conduct the Autosomal Dominant Alzheimer’s Disease (ADAD) trial as part of the Alzheimer’s Prevention Initiative (API). ADAD is a large South American trial of crenezumab in Colombian families with familial Alzheimer’s caused by mutations in the presenilin-1 gene (PSEN1).

Roche did not release any data but said the trial results will be discussed at an upcoming scientific meeting.

“While the results with crenezumab are disappointing, they meaningfully contribute to our understanding of Alzheimer’s disease,” Sandra Horning, MD, Roche’s chief medical officer and executive vice president for global development, said in an interview. “We gratefully acknowledge the participants in the CREAD trials and the efforts of everyone involved in this important program.”

The decision was not a surprise to researchers who have followed the antibody’s development. It advanced into phase 3 with lackluster phase 2 cognitive, imaging, and biomarker data. Its selection as the therapeutic agent for the ADAD trial was a key driver in its continued development, securing Roche $100 million in federal funds to help launch ADAD, the first-ever Alzheimer’s primary prevention study.

Despite its failure in sporadic Alzheimer’s, there is still some hope that crenezumab might benefit people with the PSEN1 mutation, said Richard Caselli, MD, professor of neurology at the Mayo Clinic Arizona in Scottsdale and associate director and clinical core director of the Arizona Alzheimer’s Disease Center.

“The Colombian trial is aimed at dominantly-inherited AD due to a PSEN1 mutation, so it is different enough to imagine it still might make a difference in patients in whom amyloid metabolism is actually defective due to functionally altered amyloid precursor protein or gamma secretase,” he said in an interview. “Possibly some might argue that many of the patients in the crenezumab trial likely had additional pathologies so that even if the AD component responded, the overall clinical picture might not reflect it due to the other components. That would be interesting if proven and could even argue against equating young-onset with late-onset AD, at least for clinical purposes, as is currently envisioned.”

Michael Wolfe, PhD, had a different take on the matter.

“Although amyloid-beta [Abeta] production is not necessarily altered in sporadic AD, there is essentially the same pathology, presentation, and progression with familial and sporadic AD, suggesting a common molecular mechanism,” said Dr. Wolfe, who is the Mathias P. Mertes Professor of Medicinal Chemistry at the University of Kansas, Lawrence. “It’s hard to say Abeta is the pathogenic species in familial but not sporadic AD.

The antibodies that have been failing for 5 years now were designed in the early 2000s, Dr. Kupiec pointed out, when knowledge of the various amyloid species was still immature. Newer candidates can target specific conformations of the protein – monomers and oligomers – before they aggregate into insoluble sheets. “Solanezumab was the first of these, paving the way for this new generation of antibodies,” Dr. Kupiec said.

Because they target soluble Abeta, not amyloid plaques, these domain-specific antibodies are less likely to elicit ARIA (amyloid-related imaging abnormalities), the inflammatory reaction that’s been associated with plaque dissolution in other antibody trials. ARIA has been a dose-limiting step for antiamyloid antibodies – one that conformationally targeted antibodies could avoid, Dr. Kupiec said.

“There may be some limited success with the these, and there may be enough of a treatment effect to secure approval,” he said. “The question is: Can we generate a higher effect size with an antibody that is more selective to the toxic forms of Abeta?”

PMN310 is ProMIS’ attempt to thread this needle. In preclinical studies, the antibody did not bind to amyloid monomers, plaques, or vascular Abeta aggregates. The company expects to take this antibody into phase 1 trials later this year.

“If we have a molecule that doesn’t bind to monomers or to plaques, but only to the toxic oligomer, then that is an something well worth testing in the clinic,” he said.

Dr. Caselli and Dr. Wolfe have no financial disclosures.

msullivan@mdedge.com

After a disappointing interim analysis, Roche and its collaborator AC Immune are halting two phase 3 trials of the antiamyloid antibody crenezumab.

CREAD 1 and CREAD 2 enrolled patients with prodromal-to-mild sporadic Alzheimer’s disease. The preplanned interim safety and efficacy analysis determined that neither study was likely to meet the primary endpoint of change from baseline on the Clinical Dementia Rating-sum of boxes score.

There were no unexpected safety signals associated with the drug, despite a quadrupling of the phase 3 dose from that used in phase 2. The company in its press release said that it will continue to conduct the Autosomal Dominant Alzheimer’s Disease (ADAD) trial as part of the Alzheimer’s Prevention Initiative (API). ADAD is a large South American trial of crenezumab in Colombian families with familial Alzheimer’s caused by mutations in the presenilin-1 gene (PSEN1).

Roche did not release any data but said the trial results will be discussed at an upcoming scientific meeting.

“While the results with crenezumab are disappointing, they meaningfully contribute to our understanding of Alzheimer’s disease,” Sandra Horning, MD, Roche’s chief medical officer and executive vice president for global development, said in an interview. “We gratefully acknowledge the participants in the CREAD trials and the efforts of everyone involved in this important program.”

The decision was not a surprise to researchers who have followed the antibody’s development. It advanced into phase 3 with lackluster phase 2 cognitive, imaging, and biomarker data. Its selection as the therapeutic agent for the ADAD trial was a key driver in its continued development, securing Roche $100 million in federal funds to help launch ADAD, the first-ever Alzheimer’s primary prevention study.

Despite its failure in sporadic Alzheimer’s, there is still some hope that crenezumab might benefit people with the PSEN1 mutation, said Richard Caselli, MD, professor of neurology at the Mayo Clinic Arizona in Scottsdale and associate director and clinical core director of the Arizona Alzheimer’s Disease Center.

“The Colombian trial is aimed at dominantly-inherited AD due to a PSEN1 mutation, so it is different enough to imagine it still might make a difference in patients in whom amyloid metabolism is actually defective due to functionally altered amyloid precursor protein or gamma secretase,” he said in an interview. “Possibly some might argue that many of the patients in the crenezumab trial likely had additional pathologies so that even if the AD component responded, the overall clinical picture might not reflect it due to the other components. That would be interesting if proven and could even argue against equating young-onset with late-onset AD, at least for clinical purposes, as is currently envisioned.”

Michael Wolfe, PhD, had a different take on the matter.

“Although amyloid-beta [Abeta] production is not necessarily altered in sporadic AD, there is essentially the same pathology, presentation, and progression with familial and sporadic AD, suggesting a common molecular mechanism,” said Dr. Wolfe, who is the Mathias P. Mertes Professor of Medicinal Chemistry at the University of Kansas, Lawrence. “It’s hard to say Abeta is the pathogenic species in familial but not sporadic AD.

The antibodies that have been failing for 5 years now were designed in the early 2000s, Dr. Kupiec pointed out, when knowledge of the various amyloid species was still immature. Newer candidates can target specific conformations of the protein – monomers and oligomers – before they aggregate into insoluble sheets. “Solanezumab was the first of these, paving the way for this new generation of antibodies,” Dr. Kupiec said.

Because they target soluble Abeta, not amyloid plaques, these domain-specific antibodies are less likely to elicit ARIA (amyloid-related imaging abnormalities), the inflammatory reaction that’s been associated with plaque dissolution in other antibody trials. ARIA has been a dose-limiting step for antiamyloid antibodies – one that conformationally targeted antibodies could avoid, Dr. Kupiec said.

“There may be some limited success with the these, and there may be enough of a treatment effect to secure approval,” he said. “The question is: Can we generate a higher effect size with an antibody that is more selective to the toxic forms of Abeta?”

PMN310 is ProMIS’ attempt to thread this needle. In preclinical studies, the antibody did not bind to amyloid monomers, plaques, or vascular Abeta aggregates. The company expects to take this antibody into phase 1 trials later this year.

“If we have a molecule that doesn’t bind to monomers or to plaques, but only to the toxic oligomer, then that is an something well worth testing in the clinic,” he said.

Dr. Caselli and Dr. Wolfe have no financial disclosures.

msullivan@mdedge.com

The addition of docetaxel to androgen deprivation therapy in patients with localized, high-risk prostate cancer does not appear to impact progression-free survival rates, a study has found.

In JAMA Oncology, researchers reported the results of an open-label, phase 3, randomized superiority trial comparing androgen deprivation therapy (ADT) plus docetaxel with androgen therapy alone in 254 patients who had received primary local therapy for prostate cancer but showed significant risk factors for metastatic disease.

These risk factors included positive surgical margins, a Gleason score of 8 or above, prostate-specific antigen (PSA) velocity greater than 0.75 ng/mL per year, PSA doubling time of 6 months or less, and time to PSA recurrence of 12 months or less.

Overall, 63.2% of patients in the ADT plus docetaxel group and 64.8% of the ADT-only group experienced PSA progression, defined as a 50% or more relative increase in PSA levels above the nadir. After a median follow-up of 30 months, the median PSA progression-free survival (PFS) was 20.3 months in the combined therapy arm and 19.3 months in the monotherapy arm (hazard ratio, 0.85; P = .31).

“It follows that docetaxel may not be as suitable in a high-risk setting as in a metastatic setting,” wrote Stéphane Oudard, MD, PhD, from the department of medical oncology at Georges Pompidou Hospital in Paris, and his coauthors.

However individuals in the combined therapy arm showed a significantly higher complete PSA response rate, compared with those in the ADT-only group (72.8% vs. 64.8%).

In subgroup analysis, based on the various risk factors for progression to metastatic disease, the combined therapy approach was always better than the monotherapy in PSA PFS, but never achieved statistical significance. The authors noted a 15% improvement in time to PSA progression with combined therapy.

Researchers followed the group for a median of 10.5 years, during which time they saw a similar median time to radiologic progression in both arms (8.9 years for ADT plus docetaxel and 9 years for ADT alone; HR, 1.03; P = 0.88).

There was also no significant difference in all-cause mortality between the two groups.

The authors acknowledged that the clinical relevance of their chosen end point of PSA PFS was likely to be disputed, as some preferred to use endpoints such as prostate cancer mortality, metastasis-free survival, or time to metastasis.

“However, PSA PFS was an appropriate choice within our study setting and time frame because PFS depends on any subsequent PSA relapse management [e.g., reintroduction of intermittent or continuous ADT, administration of new drugs] and regular PSA sampling for landmark analyses would have been more difficult to obtain as main endpoint.”

The study was supported by Sanofi, Ipsen, and the Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie. Four authors reported receiving funding from private industry, including the study sponsors, either during the conduct of the study or outside it.

SOURCE: Oudard S et al. JAMA Oncol. 2019 Jan 31. doi: 10.1001/jamaoncol.2018.6607.

The addition of docetaxel to androgen deprivation therapy in patients with localized, high-risk prostate cancer does not appear to impact progression-free survival rates, a study has found.

In JAMA Oncology, researchers reported the results of an open-label, phase 3, randomized superiority trial comparing androgen deprivation therapy (ADT) plus docetaxel with androgen therapy alone in 254 patients who had received primary local therapy for prostate cancer but showed significant risk factors for metastatic disease.

These risk factors included positive surgical margins, a Gleason score of 8 or above, prostate-specific antigen (PSA) velocity greater than 0.75 ng/mL per year, PSA doubling time of 6 months or less, and time to PSA recurrence of 12 months or less.

Overall, 63.2% of patients in the ADT plus docetaxel group and 64.8% of the ADT-only group experienced PSA progression, defined as a 50% or more relative increase in PSA levels above the nadir. After a median follow-up of 30 months, the median PSA progression-free survival (PFS) was 20.3 months in the combined therapy arm and 19.3 months in the monotherapy arm (hazard ratio, 0.85; P = .31).

“It follows that docetaxel may not be as suitable in a high-risk setting as in a metastatic setting,” wrote Stéphane Oudard, MD, PhD, from the department of medical oncology at Georges Pompidou Hospital in Paris, and his coauthors.

However individuals in the combined therapy arm showed a significantly higher complete PSA response rate, compared with those in the ADT-only group (72.8% vs. 64.8%).

In subgroup analysis, based on the various risk factors for progression to metastatic disease, the combined therapy approach was always better than the monotherapy in PSA PFS, but never achieved statistical significance. The authors noted a 15% improvement in time to PSA progression with combined therapy.

Researchers followed the group for a median of 10.5 years, during which time they saw a similar median time to radiologic progression in both arms (8.9 years for ADT plus docetaxel and 9 years for ADT alone; HR, 1.03; P = 0.88).

There was also no significant difference in all-cause mortality between the two groups.

The authors acknowledged that the clinical relevance of their chosen end point of PSA PFS was likely to be disputed, as some preferred to use endpoints such as prostate cancer mortality, metastasis-free survival, or time to metastasis.

“However, PSA PFS was an appropriate choice within our study setting and time frame because PFS depends on any subsequent PSA relapse management [e.g., reintroduction of intermittent or continuous ADT, administration of new drugs] and regular PSA sampling for landmark analyses would have been more difficult to obtain as main endpoint.”

The study was supported by Sanofi, Ipsen, and the Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie. Four authors reported receiving funding from private industry, including the study sponsors, either during the conduct of the study or outside it.

SOURCE: Oudard S et al. JAMA Oncol. 2019 Jan 31. doi: 10.1001/jamaoncol.2018.6607.

The addition of docetaxel to androgen deprivation therapy in patients with localized, high-risk prostate cancer does not appear to impact progression-free survival rates, a study has found.

In JAMA Oncology, researchers reported the results of an open-label, phase 3, randomized superiority trial comparing androgen deprivation therapy (ADT) plus docetaxel with androgen therapy alone in 254 patients who had received primary local therapy for prostate cancer but showed significant risk factors for metastatic disease.

These risk factors included positive surgical margins, a Gleason score of 8 or above, prostate-specific antigen (PSA) velocity greater than 0.75 ng/mL per year, PSA doubling time of 6 months or less, and time to PSA recurrence of 12 months or less.

Overall, 63.2% of patients in the ADT plus docetaxel group and 64.8% of the ADT-only group experienced PSA progression, defined as a 50% or more relative increase in PSA levels above the nadir. After a median follow-up of 30 months, the median PSA progression-free survival (PFS) was 20.3 months in the combined therapy arm and 19.3 months in the monotherapy arm (hazard ratio, 0.85; P = .31).

“It follows that docetaxel may not be as suitable in a high-risk setting as in a metastatic setting,” wrote Stéphane Oudard, MD, PhD, from the department of medical oncology at Georges Pompidou Hospital in Paris, and his coauthors.

However individuals in the combined therapy arm showed a significantly higher complete PSA response rate, compared with those in the ADT-only group (72.8% vs. 64.8%).

In subgroup analysis, based on the various risk factors for progression to metastatic disease, the combined therapy approach was always better than the monotherapy in PSA PFS, but never achieved statistical significance. The authors noted a 15% improvement in time to PSA progression with combined therapy.

Researchers followed the group for a median of 10.5 years, during which time they saw a similar median time to radiologic progression in both arms (8.9 years for ADT plus docetaxel and 9 years for ADT alone; HR, 1.03; P = 0.88).

There was also no significant difference in all-cause mortality between the two groups.

The authors acknowledged that the clinical relevance of their chosen end point of PSA PFS was likely to be disputed, as some preferred to use endpoints such as prostate cancer mortality, metastasis-free survival, or time to metastasis.

“However, PSA PFS was an appropriate choice within our study setting and time frame because PFS depends on any subsequent PSA relapse management [e.g., reintroduction of intermittent or continuous ADT, administration of new drugs] and regular PSA sampling for landmark analyses would have been more difficult to obtain as main endpoint.”

The study was supported by Sanofi, Ipsen, and the Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie. Four authors reported receiving funding from private industry, including the study sponsors, either during the conduct of the study or outside it.

SOURCE: Oudard S et al. JAMA Oncol. 2019 Jan 31. doi: 10.1001/jamaoncol.2018.6607.

LA JOLLA, CALIF. – Results from the ECHELON-2 trial led to the U.S. approval of brentuximab vedotin (BV) in combination with cyclophosphamide, doxorubicin, and prednisone (CHP), but there are still questions about how to apply the trial results to practice.

Vidyard Video

At the annual T-cell Lymphoma Forum, trial investigators and other physicians debated the best use of this combination.

BV-CHP is approved to treat patients with previously untreated systemic anaplastic large-cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (NOS).

Patients who received BV-CHP in ECHELON-2 had superior progression-free survival (PFS) and overall survival (OS) compared to patients who received cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).

These results were initially presented at the 2018 annual meeting of the American Society of Hematology and simultaneously published in The Lancet (2019 Jan 19;393[10168]:229-40).

ECHELON-2 investigator Owen O’Connor, MD, PhD, of Columbia University Medical Center in New York, also presented details on the trial at the T-cell Lymphoma Forum. His presentation was followed by a discussion with meeting attendees about applying the trial results to clinical practice.

CD30 expression

One of the issues discussed was the importance of CD30 expression in deciding which patients should receive BV.

For a patient to be eligible for ECHELON-2, the diagnostic biopsy had to show at least 10% of the neoplastic cells were CD30-positive. However, the Food and Drug Administration (FDA) has not made a similar requirement for prescribing BV. PTCL patients with any level of CD30 expression are eligible for treatment with BV-CHP, according to the FDA.

“[I]t’s still a matter of great debate and controversy as to whether we have good enough data to suggest that there’s a threshold effect with regard to the expression of CD30 and responsiveness or sensitivity to brentuximab vedotin,” Dr. O’Connor said.

“This has been an issue from the very first day with this drug, which is, ‘Just how much CD30 do you need to get a response?’ I can’t speak on behalf of the FDA, but I think they are not absolutely convinced that there’s a threshold. They take [CD30-] positive as ‘good enough’ across the board.”

“The FDA has said, ‘The data we’ve seen says there’s a lot of heterogeneity [with biopsies].’ You may do a biopsy and find 30% [of cells are CD30-positive], and you may do another biopsy [in the same patient] and find less than 10%. I don’t think the regulatory agencies are convinced that a single biopsy looking at CD30 ... is representative of the entire tumor burden.”

Andrei Shustov, MD, an ECHELON-2 investigator from the University of Washington in Seattle, questioned whether CD30 expression should be considered when deciding on the use of BV in PTCL.

“Is CD30 staining relevant at all, or should we default back to studies, say, in colon cancer where we didn’t even care about EGFR because we might be missing it by current techniques?” Dr. Shustov asked. “Should we even worry about CD30 expression ... because we cannot reliably detect low levels of CD30?”

Some attendees echoed this sentiment, questioning the utility of assessing CD30 expression. Other attendees said they would defer to the trial data and only treat patients with BV-CHP if they had at least 10% CD30.

 

 

PTCL subtypes

Meeting attendees also discussed the value of BV in different PTCL subtypes.

At the request of European regulatory agencies, ECHELON-2 was largely focused on patients with sALCL. They made up 70% of the total trial population, while 16% of patients had PTCL-NOS, 12% had AITL, and a small number of patients had other subtypes. These numbers meant ECHELON-2 was not powered to determine differences in OS or PFS in non-sALCL subtypes.

As a result, some attendees expressed concerns about using BV-CHP to treat PTCL-NOS or AITL. They argued that it wasn’t clear whether patients with these subtypes would derive more benefit from BV-CHP, CHOP, or CHOP plus etoposide (CHOEP).

Other attendees said they would feel comfortable using BV-CHP in patients with PTCL-NOS or AITL based on ECHELON-2 results.
 

CHOP vs. CHOEP

The use of CHOP in ECHELON-2 was another point of discussion. Some attendees said CHOEP should have been used as the comparator instead.

A few individuals mentioned retrospective data suggesting CHOEP may confer a benefit over CHOP in PTCL (Blood. 2010 Nov 4;116[18]:3418-25).

Marek Trneny, MD, of Charles University General Hospital in Prague, referenced new data from the Czech National Lymphoma Registry, which showed that patients newly diagnosed with PTCL had superior PFS and OS when they received CHOEP rather than CHOP.

Based on these findings, Dr. Trneny said he would consider treating CD30-positive PTCL patients with CHOEP plus BV rather than BV-CHP.

However, most other attendees said they would not consider adding BV to CHOEP due to the absence of clinical trial data supporting this approach.

Some attendees did say they would use CHOEP instead of BV-CHP, particularly in patients with PTCL-NOS or AITL and in patients with CD30 expression below 10%.

ECHELON-2 was funded by Seattle Genetics and Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company.

Dr. O’Connor and Dr. Shustov were investigators on ECHELON-2. Dr. O’Connor is a cochair of the T-cell Lymphoma Forum. The T-cell Lymphoma Forum is organized by Jonathan Wood & Associates, which is owned by the same company as this news organization.

jensmith@mdedge.com

LA JOLLA, CALIF. – Results from the ECHELON-2 trial led to the U.S. approval of brentuximab vedotin (BV) in combination with cyclophosphamide, doxorubicin, and prednisone (CHP), but there are still questions about how to apply the trial results to practice.

Vidyard Video

At the annual T-cell Lymphoma Forum, trial investigators and other physicians debated the best use of this combination.

BV-CHP is approved to treat patients with previously untreated systemic anaplastic large-cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (NOS).

Patients who received BV-CHP in ECHELON-2 had superior progression-free survival (PFS) and overall survival (OS) compared to patients who received cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).

These results were initially presented at the 2018 annual meeting of the American Society of Hematology and simultaneously published in The Lancet (2019 Jan 19;393[10168]:229-40).

ECHELON-2 investigator Owen O’Connor, MD, PhD, of Columbia University Medical Center in New York, also presented details on the trial at the T-cell Lymphoma Forum. His presentation was followed by a discussion with meeting attendees about applying the trial results to clinical practice.

CD30 expression

One of the issues discussed was the importance of CD30 expression in deciding which patients should receive BV.

For a patient to be eligible for ECHELON-2, the diagnostic biopsy had to show at least 10% of the neoplastic cells were CD30-positive. However, the Food and Drug Administration (FDA) has not made a similar requirement for prescribing BV. PTCL patients with any level of CD30 expression are eligible for treatment with BV-CHP, according to the FDA.

“[I]t’s still a matter of great debate and controversy as to whether we have good enough data to suggest that there’s a threshold effect with regard to the expression of CD30 and responsiveness or sensitivity to brentuximab vedotin,” Dr. O’Connor said.

“This has been an issue from the very first day with this drug, which is, ‘Just how much CD30 do you need to get a response?’ I can’t speak on behalf of the FDA, but I think they are not absolutely convinced that there’s a threshold. They take [CD30-] positive as ‘good enough’ across the board.”

“The FDA has said, ‘The data we’ve seen says there’s a lot of heterogeneity [with biopsies].’ You may do a biopsy and find 30% [of cells are CD30-positive], and you may do another biopsy [in the same patient] and find less than 10%. I don’t think the regulatory agencies are convinced that a single biopsy looking at CD30 ... is representative of the entire tumor burden.”

Andrei Shustov, MD, an ECHELON-2 investigator from the University of Washington in Seattle, questioned whether CD30 expression should be considered when deciding on the use of BV in PTCL.

“Is CD30 staining relevant at all, or should we default back to studies, say, in colon cancer where we didn’t even care about EGFR because we might be missing it by current techniques?” Dr. Shustov asked. “Should we even worry about CD30 expression ... because we cannot reliably detect low levels of CD30?”

Some attendees echoed this sentiment, questioning the utility of assessing CD30 expression. Other attendees said they would defer to the trial data and only treat patients with BV-CHP if they had at least 10% CD30.

 

 

PTCL subtypes

Meeting attendees also discussed the value of BV in different PTCL subtypes.

At the request of European regulatory agencies, ECHELON-2 was largely focused on patients with sALCL. They made up 70% of the total trial population, while 16% of patients had PTCL-NOS, 12% had AITL, and a small number of patients had other subtypes. These numbers meant ECHELON-2 was not powered to determine differences in OS or PFS in non-sALCL subtypes.

As a result, some attendees expressed concerns about using BV-CHP to treat PTCL-NOS or AITL. They argued that it wasn’t clear whether patients with these subtypes would derive more benefit from BV-CHP, CHOP, or CHOP plus etoposide (CHOEP).

Other attendees said they would feel comfortable using BV-CHP in patients with PTCL-NOS or AITL based on ECHELON-2 results.
 

CHOP vs. CHOEP

The use of CHOP in ECHELON-2 was another point of discussion. Some attendees said CHOEP should have been used as the comparator instead.

A few individuals mentioned retrospective data suggesting CHOEP may confer a benefit over CHOP in PTCL (Blood. 2010 Nov 4;116[18]:3418-25).

Marek Trneny, MD, of Charles University General Hospital in Prague, referenced new data from the Czech National Lymphoma Registry, which showed that patients newly diagnosed with PTCL had superior PFS and OS when they received CHOEP rather than CHOP.

Based on these findings, Dr. Trneny said he would consider treating CD30-positive PTCL patients with CHOEP plus BV rather than BV-CHP.

However, most other attendees said they would not consider adding BV to CHOEP due to the absence of clinical trial data supporting this approach.

Some attendees did say they would use CHOEP instead of BV-CHP, particularly in patients with PTCL-NOS or AITL and in patients with CD30 expression below 10%.

ECHELON-2 was funded by Seattle Genetics and Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company.

Dr. O’Connor and Dr. Shustov were investigators on ECHELON-2. Dr. O’Connor is a cochair of the T-cell Lymphoma Forum. The T-cell Lymphoma Forum is organized by Jonathan Wood & Associates, which is owned by the same company as this news organization.

jensmith@mdedge.com

LA JOLLA, CALIF. – Results from the ECHELON-2 trial led to the U.S. approval of brentuximab vedotin (BV) in combination with cyclophosphamide, doxorubicin, and prednisone (CHP), but there are still questions about how to apply the trial results to practice.

Vidyard Video

At the annual T-cell Lymphoma Forum, trial investigators and other physicians debated the best use of this combination.

BV-CHP is approved to treat patients with previously untreated systemic anaplastic large-cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (NOS).

Patients who received BV-CHP in ECHELON-2 had superior progression-free survival (PFS) and overall survival (OS) compared to patients who received cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).

These results were initially presented at the 2018 annual meeting of the American Society of Hematology and simultaneously published in The Lancet (2019 Jan 19;393[10168]:229-40).

ECHELON-2 investigator Owen O’Connor, MD, PhD, of Columbia University Medical Center in New York, also presented details on the trial at the T-cell Lymphoma Forum. His presentation was followed by a discussion with meeting attendees about applying the trial results to clinical practice.

CD30 expression

One of the issues discussed was the importance of CD30 expression in deciding which patients should receive BV.

For a patient to be eligible for ECHELON-2, the diagnostic biopsy had to show at least 10% of the neoplastic cells were CD30-positive. However, the Food and Drug Administration (FDA) has not made a similar requirement for prescribing BV. PTCL patients with any level of CD30 expression are eligible for treatment with BV-CHP, according to the FDA.

“[I]t’s still a matter of great debate and controversy as to whether we have good enough data to suggest that there’s a threshold effect with regard to the expression of CD30 and responsiveness or sensitivity to brentuximab vedotin,” Dr. O’Connor said.

“This has been an issue from the very first day with this drug, which is, ‘Just how much CD30 do you need to get a response?’ I can’t speak on behalf of the FDA, but I think they are not absolutely convinced that there’s a threshold. They take [CD30-] positive as ‘good enough’ across the board.”

“The FDA has said, ‘The data we’ve seen says there’s a lot of heterogeneity [with biopsies].’ You may do a biopsy and find 30% [of cells are CD30-positive], and you may do another biopsy [in the same patient] and find less than 10%. I don’t think the regulatory agencies are convinced that a single biopsy looking at CD30 ... is representative of the entire tumor burden.”

Andrei Shustov, MD, an ECHELON-2 investigator from the University of Washington in Seattle, questioned whether CD30 expression should be considered when deciding on the use of BV in PTCL.

“Is CD30 staining relevant at all, or should we default back to studies, say, in colon cancer where we didn’t even care about EGFR because we might be missing it by current techniques?” Dr. Shustov asked. “Should we even worry about CD30 expression ... because we cannot reliably detect low levels of CD30?”

Some attendees echoed this sentiment, questioning the utility of assessing CD30 expression. Other attendees said they would defer to the trial data and only treat patients with BV-CHP if they had at least 10% CD30.

 

 

PTCL subtypes

Meeting attendees also discussed the value of BV in different PTCL subtypes.

At the request of European regulatory agencies, ECHELON-2 was largely focused on patients with sALCL. They made up 70% of the total trial population, while 16% of patients had PTCL-NOS, 12% had AITL, and a small number of patients had other subtypes. These numbers meant ECHELON-2 was not powered to determine differences in OS or PFS in non-sALCL subtypes.

As a result, some attendees expressed concerns about using BV-CHP to treat PTCL-NOS or AITL. They argued that it wasn’t clear whether patients with these subtypes would derive more benefit from BV-CHP, CHOP, or CHOP plus etoposide (CHOEP).

Other attendees said they would feel comfortable using BV-CHP in patients with PTCL-NOS or AITL based on ECHELON-2 results.
 

CHOP vs. CHOEP

The use of CHOP in ECHELON-2 was another point of discussion. Some attendees said CHOEP should have been used as the comparator instead.

A few individuals mentioned retrospective data suggesting CHOEP may confer a benefit over CHOP in PTCL (Blood. 2010 Nov 4;116[18]:3418-25).

Marek Trneny, MD, of Charles University General Hospital in Prague, referenced new data from the Czech National Lymphoma Registry, which showed that patients newly diagnosed with PTCL had superior PFS and OS when they received CHOEP rather than CHOP.

Based on these findings, Dr. Trneny said he would consider treating CD30-positive PTCL patients with CHOEP plus BV rather than BV-CHP.

However, most other attendees said they would not consider adding BV to CHOEP due to the absence of clinical trial data supporting this approach.

Some attendees did say they would use CHOEP instead of BV-CHP, particularly in patients with PTCL-NOS or AITL and in patients with CD30 expression below 10%.

ECHELON-2 was funded by Seattle Genetics and Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company.

Dr. O’Connor and Dr. Shustov were investigators on ECHELON-2. Dr. O’Connor is a cochair of the T-cell Lymphoma Forum. The T-cell Lymphoma Forum is organized by Jonathan Wood & Associates, which is owned by the same company as this news organization.

jensmith@mdedge.com

One evening in 2016, my 9-year-old son suggested we use Bitcoin to purchase something on the Microsoft Xbox store. Surprised by his suggestion, I was suddenly struck with two thoughts: 1) Microsoft, by accepting Bitcoin, was validating cryptocurrency as a credible form of payment, and 2) I was getting old. My 9-year-old seemed to have a better understanding of a new technology than I did, hardly the first time – or the last time – that happened. In spite of my initial feelings of defeat, I resolved not to cede victory to my son without a fight. I immediately set out to understand cryptocurrencies and, more importantly, the technology underpinning them known as blockchain.

matejmo/iStock/Getty Images

Even just a few years ago, my ignorance of how blockchains work may have been acceptable, but it hardly seems acceptable now. Much more than just cryptocurrency, blockchain technology is beginning to affect every industry that values information sharing and security, and it is about to usher in a revolution in health care. But what are blockchains, and why are they so important?

Explaining blockchains

Blockchains were first conceptualized almost 3 decades ago, but the invention of the first blockchain as we know it today occurred in 2008 by Satoshi Nakomoto, creator of Bitcoin. Blockchains can be thought of as a way to store and communicate information while ensuring its integrity and security. Admittedly, the technology can be a bit confusing, but we’ll attempt to simplify it by focusing on a few fundamental elements.

As the name indicates, the blockchain model relies on a chain of connected blocks. Each block contains some data (which can be financial, medical, legal, or anything else) and bears a unique fingerprint known as a “hash.” Each hash is different and depends entirely on the data stored in the block. In other words, if the contents of the block change, the hash changes, creating an entirely new fingerprint. Each block on the chain also keeps a record of the hash of the previous block. This “links” the chain together, and is the first key to its robust security: If any block is tampered with, its fingerprint will change and it will no longer be linked, thus invalidating all following blocks on the chain.

Ensuring the integrity of the blockchain doesn’t stop there. Just as actual fingerprints can be spoofed by enterprising criminals, hash technology isn’t enough to provide complete security. Thus, several other security features are built into blockchains, with the most noteworthy and important being “decentralization.” This means that blockchains are not stored on any single computer. On the contrary, duplicate copies of every blockchain exist on thousands of computers around the world, creating redundancy and minimizing the vulnerability that any single chain could be tampered with. Before any change in the blockchain can be made and accepted, it must be validated by a majority of the computers storing the chain.

If this all seems perplexing, that’s because it is. Blockchains are complex and difficult to visualize. (But if you’d like a deeper understanding, there are many great YouTube videos that do a great job explaining them.) For now, just remember this: Blockchains are very secure yet highly accessible, and will be essential to how data – especially health data – are stored and communicated in the future.

Blockchains in health care

On Jan. 24, 2019, five major companies (Aetna, Anthem, Health Care Services, IBM, and PNC Bank) “announced a new collaboration to design and create a network using blockchain technology to improve transparency and interoperability in the health care industry.”¹ This team of industry leaders is hoping to build the engine that will power the future and impact how health records are created, maintained, and communicated. They’ll achieve this by taking advantage of blockchain’s inclusiveness and decentralization, storing records in a manner that is safe and accessible anywhere a patient seeks care. Because of the redundancy built into blockchains, they can also ensure data integrity. Physicians will benefit from information that is easy to obtain and always accurate; patients will benefit by gaining greater access and ownership of their personal medical records.

The collaboration mentioned above is the latest, but certainly not the first, attempt to exploit the benefits of blockchain for health care. Other major players have already entered the game, and the field is growing quickly. While it’s easy to find their efforts admirable, corporate involvement also means there is money to be saved or made in the space. Chris Ward, head of product for PNC Treasury Management, alluded to this as he commented publicly in the press release: “This collaboration will enable health care–related data and business transactions to occur in way that addresses market demands for transparency and security, while making it easier for the patient, payer, and provider to handle payments. Using this technology, we can remove friction, duplication, and administrative costs that continue to plague the industry.”

Industry executives recognize that interoperability is still the greatest challenge facing the future of health care and are particularly sensitive to the costs of not facing the challenge successfully. Clearly, they see an investment in blockchains as an opportunity to be part of a financially beneficial solution.

Why we should care

As we’ve now covered, there are many advantages of blockchain technology. In fact, we see it as the natural evolution of the patient-centered EHR. Instead of siloed and proprietary information spread across disparate EHRs that can’t communicate, the future of data exchange will be more transparent, yet more secure. Blockchain represents a unique opportunity to democratize the availability of health care information while increasing information quality and lowering costs. It is also shaping up to be the way we’ll exchange sensitive data in the future.

Don’t believe us? Just ask any 9-year-old.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter, @doctornotte. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

Reference

1. https://newsroom.ibm.com/2019-01-24-Aetna-Anthem-Health-Care-Service-Corporation-PNC-Bank-and-IBM-announce-collaboration-to-establish-blockchain-based-ecosystem-for-the-healthcare-industry

One evening in 2016, my 9-year-old son suggested we use Bitcoin to purchase something on the Microsoft Xbox store. Surprised by his suggestion, I was suddenly struck with two thoughts: 1) Microsoft, by accepting Bitcoin, was validating cryptocurrency as a credible form of payment, and 2) I was getting old. My 9-year-old seemed to have a better understanding of a new technology than I did, hardly the first time – or the last time – that happened. In spite of my initial feelings of defeat, I resolved not to cede victory to my son without a fight. I immediately set out to understand cryptocurrencies and, more importantly, the technology underpinning them known as blockchain.

matejmo/iStock/Getty Images

Even just a few years ago, my ignorance of how blockchains work may have been acceptable, but it hardly seems acceptable now. Much more than just cryptocurrency, blockchain technology is beginning to affect every industry that values information sharing and security, and it is about to usher in a revolution in health care. But what are blockchains, and why are they so important?

Explaining blockchains

Blockchains were first conceptualized almost 3 decades ago, but the invention of the first blockchain as we know it today occurred in 2008 by Satoshi Nakomoto, creator of Bitcoin. Blockchains can be thought of as a way to store and communicate information while ensuring its integrity and security. Admittedly, the technology can be a bit confusing, but we’ll attempt to simplify it by focusing on a few fundamental elements.

As the name indicates, the blockchain model relies on a chain of connected blocks. Each block contains some data (which can be financial, medical, legal, or anything else) and bears a unique fingerprint known as a “hash.” Each hash is different and depends entirely on the data stored in the block. In other words, if the contents of the block change, the hash changes, creating an entirely new fingerprint. Each block on the chain also keeps a record of the hash of the previous block. This “links” the chain together, and is the first key to its robust security: If any block is tampered with, its fingerprint will change and it will no longer be linked, thus invalidating all following blocks on the chain.

Ensuring the integrity of the blockchain doesn’t stop there. Just as actual fingerprints can be spoofed by enterprising criminals, hash technology isn’t enough to provide complete security. Thus, several other security features are built into blockchains, with the most noteworthy and important being “decentralization.” This means that blockchains are not stored on any single computer. On the contrary, duplicate copies of every blockchain exist on thousands of computers around the world, creating redundancy and minimizing the vulnerability that any single chain could be tampered with. Before any change in the blockchain can be made and accepted, it must be validated by a majority of the computers storing the chain.

If this all seems perplexing, that’s because it is. Blockchains are complex and difficult to visualize. (But if you’d like a deeper understanding, there are many great YouTube videos that do a great job explaining them.) For now, just remember this: Blockchains are very secure yet highly accessible, and will be essential to how data – especially health data – are stored and communicated in the future.

Blockchains in health care

On Jan. 24, 2019, five major companies (Aetna, Anthem, Health Care Services, IBM, and PNC Bank) “announced a new collaboration to design and create a network using blockchain technology to improve transparency and interoperability in the health care industry.”¹ This team of industry leaders is hoping to build the engine that will power the future and impact how health records are created, maintained, and communicated. They’ll achieve this by taking advantage of blockchain’s inclusiveness and decentralization, storing records in a manner that is safe and accessible anywhere a patient seeks care. Because of the redundancy built into blockchains, they can also ensure data integrity. Physicians will benefit from information that is easy to obtain and always accurate; patients will benefit by gaining greater access and ownership of their personal medical records.

The collaboration mentioned above is the latest, but certainly not the first, attempt to exploit the benefits of blockchain for health care. Other major players have already entered the game, and the field is growing quickly. While it’s easy to find their efforts admirable, corporate involvement also means there is money to be saved or made in the space. Chris Ward, head of product for PNC Treasury Management, alluded to this as he commented publicly in the press release: “This collaboration will enable health care–related data and business transactions to occur in way that addresses market demands for transparency and security, while making it easier for the patient, payer, and provider to handle payments. Using this technology, we can remove friction, duplication, and administrative costs that continue to plague the industry.”

Industry executives recognize that interoperability is still the greatest challenge facing the future of health care and are particularly sensitive to the costs of not facing the challenge successfully. Clearly, they see an investment in blockchains as an opportunity to be part of a financially beneficial solution.

Why we should care

As we’ve now covered, there are many advantages of blockchain technology. In fact, we see it as the natural evolution of the patient-centered EHR. Instead of siloed and proprietary information spread across disparate EHRs that can’t communicate, the future of data exchange will be more transparent, yet more secure. Blockchain represents a unique opportunity to democratize the availability of health care information while increasing information quality and lowering costs. It is also shaping up to be the way we’ll exchange sensitive data in the future.

Don’t believe us? Just ask any 9-year-old.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter, @doctornotte. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

Reference

1. https://newsroom.ibm.com/2019-01-24-Aetna-Anthem-Health-Care-Service-Corporation-PNC-Bank-and-IBM-announce-collaboration-to-establish-blockchain-based-ecosystem-for-the-healthcare-industry

One evening in 2016, my 9-year-old son suggested we use Bitcoin to purchase something on the Microsoft Xbox store. Surprised by his suggestion, I was suddenly struck with two thoughts: 1) Microsoft, by accepting Bitcoin, was validating cryptocurrency as a credible form of payment, and 2) I was getting old. My 9-year-old seemed to have a better understanding of a new technology than I did, hardly the first time – or the last time – that happened. In spite of my initial feelings of defeat, I resolved not to cede victory to my son without a fight. I immediately set out to understand cryptocurrencies and, more importantly, the technology underpinning them known as blockchain.

matejmo/iStock/Getty Images

Even just a few years ago, my ignorance of how blockchains work may have been acceptable, but it hardly seems acceptable now. Much more than just cryptocurrency, blockchain technology is beginning to affect every industry that values information sharing and security, and it is about to usher in a revolution in health care. But what are blockchains, and why are they so important?

Explaining blockchains

Blockchains were first conceptualized almost 3 decades ago, but the invention of the first blockchain as we know it today occurred in 2008 by Satoshi Nakomoto, creator of Bitcoin. Blockchains can be thought of as a way to store and communicate information while ensuring its integrity and security. Admittedly, the technology can be a bit confusing, but we’ll attempt to simplify it by focusing on a few fundamental elements.

As the name indicates, the blockchain model relies on a chain of connected blocks. Each block contains some data (which can be financial, medical, legal, or anything else) and bears a unique fingerprint known as a “hash.” Each hash is different and depends entirely on the data stored in the block. In other words, if the contents of the block change, the hash changes, creating an entirely new fingerprint. Each block on the chain also keeps a record of the hash of the previous block. This “links” the chain together, and is the first key to its robust security: If any block is tampered with, its fingerprint will change and it will no longer be linked, thus invalidating all following blocks on the chain.

Ensuring the integrity of the blockchain doesn’t stop there. Just as actual fingerprints can be spoofed by enterprising criminals, hash technology isn’t enough to provide complete security. Thus, several other security features are built into blockchains, with the most noteworthy and important being “decentralization.” This means that blockchains are not stored on any single computer. On the contrary, duplicate copies of every blockchain exist on thousands of computers around the world, creating redundancy and minimizing the vulnerability that any single chain could be tampered with. Before any change in the blockchain can be made and accepted, it must be validated by a majority of the computers storing the chain.

If this all seems perplexing, that’s because it is. Blockchains are complex and difficult to visualize. (But if you’d like a deeper understanding, there are many great YouTube videos that do a great job explaining them.) For now, just remember this: Blockchains are very secure yet highly accessible, and will be essential to how data – especially health data – are stored and communicated in the future.

Blockchains in health care

On Jan. 24, 2019, five major companies (Aetna, Anthem, Health Care Services, IBM, and PNC Bank) “announced a new collaboration to design and create a network using blockchain technology to improve transparency and interoperability in the health care industry.”¹ This team of industry leaders is hoping to build the engine that will power the future and impact how health records are created, maintained, and communicated. They’ll achieve this by taking advantage of blockchain’s inclusiveness and decentralization, storing records in a manner that is safe and accessible anywhere a patient seeks care. Because of the redundancy built into blockchains, they can also ensure data integrity. Physicians will benefit from information that is easy to obtain and always accurate; patients will benefit by gaining greater access and ownership of their personal medical records.

The collaboration mentioned above is the latest, but certainly not the first, attempt to exploit the benefits of blockchain for health care. Other major players have already entered the game, and the field is growing quickly. While it’s easy to find their efforts admirable, corporate involvement also means there is money to be saved or made in the space. Chris Ward, head of product for PNC Treasury Management, alluded to this as he commented publicly in the press release: “This collaboration will enable health care–related data and business transactions to occur in way that addresses market demands for transparency and security, while making it easier for the patient, payer, and provider to handle payments. Using this technology, we can remove friction, duplication, and administrative costs that continue to plague the industry.”

Industry executives recognize that interoperability is still the greatest challenge facing the future of health care and are particularly sensitive to the costs of not facing the challenge successfully. Clearly, they see an investment in blockchains as an opportunity to be part of a financially beneficial solution.

Why we should care

As we’ve now covered, there are many advantages of blockchain technology. In fact, we see it as the natural evolution of the patient-centered EHR. Instead of siloed and proprietary information spread across disparate EHRs that can’t communicate, the future of data exchange will be more transparent, yet more secure. Blockchain represents a unique opportunity to democratize the availability of health care information while increasing information quality and lowering costs. It is also shaping up to be the way we’ll exchange sensitive data in the future.

Don’t believe us? Just ask any 9-year-old.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter, @doctornotte. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

Reference

1. https://newsroom.ibm.com/2019-01-24-Aetna-Anthem-Health-Care-Service-Corporation-PNC-Bank-and-IBM-announce-collaboration-to-establish-blockchain-based-ecosystem-for-the-healthcare-industry

Every year, thousands of us vow to “get in shape” by eating right and exercising. (Whether we keep that resolution is another story.) But while we view physical exercise as a way to lose or maintain weight, reduce stress, or even hone athletic skills, we seldom think about exercising one of the most important muscles in our body: the brain.

“What?” you say. “The brain is not like other muscles.” No, it’s not … and yet, it isn’t as different as we used to think. Historically (maybe histologically?), it was believed that if nerve cells in the adult brain were damaged or had died, they, unlike other cells in the body, were not replaced. Longstanding scientific belief was that while the brain compensated for damage by making new connections to undamaged nerve cells, it could not regenerate because it does not contain stem cells.¹

But since the late 1990s, scientists have been debunking the negative myths about our brains as we age. They are not as static and unable to change as we have been led to fear! In fact, in 1998, American and Swedish scientists demonstrated that adult humans can generate new brain cells.^1,2 Moreover, the brain does replicate neurons in the hippocampus, the area in our brains that is central to learning and memory. Neurons continue to grow and change beyond the first years of development and well into adulthood.

So learning (and teaching) movements to encourage the rebuilding of our neurons is key to keeping our minds sharp. In his work, Ratey found that “our physical movements can directly influence our ability to learn, think, and remember.”³ He also tells us that exercise enhances circulation to the brain, “priming it for improved function, including mental health as well as cognitive ability.”⁴

No, you can’t put your brain on a treadmill to get, and help keep, it “in shape.” But you can do something to maintain mental sharpness and delay decline in mental agility. And these exercises don’t require a health club membership or special equipment. They can be done anytime, anywhere … and no one knows you are doing them!

I’m talking about neurobics, a term coined to describe exercises that keep us mentally fit.⁵ The purpose of these activities is to work our brains in nonroutine or unexpected ways, using all of our senses to experience, or re-experience, a common activity.

Not sure what that means? Here are some examples:

Spend time in a new environment. Go to a different park or a new store. Travel, by the way, seems to slow age-related mental decline.

Continue to: Smell new odors in the morning

Smell new odors in the morning. Have new scents, like a bottle of mint extract, ready to smell first thing in the morning, to “wake up” your brain.

Take a shower with your eyes closed. Other senses become more active when you cannot see, and a shower engages several.

Try brushing your teeth with your nondominant hand. This may be difficult for some of us—and it definitely requires full attention the first time you try it!

Learn to read braille. This is a tough one, but learning to read with your fingers definitely involves one of your senses in a new context. Or, you could try learning American Sign Language, which also uses your fingers to communicate.

Respond to a situation differently. Catch yourself in a normal, unconscious response to a situation, and choose to respond in an alternate (and preferably better) way.

Continue to: Find a new route to work

Find a new route to work. It doesn’t have to be longer, just different. You may even find a faster way to work once you break your routine.

Act confidently. In a situation you are unsure about, choose to act confidently. You’ll notice that your mind gets very active once you adopt the assumption that you will know what to do.

Distinguish coins using only your sense of touch. This brain exercise can be used to kill time while waiting for an appointment. If you really want a challenge, see if you can distinguish paper currency denominations by touch.

Leave the lights off in the house. Get around your home by memory and feel. This certainly fully engages your attention—but be careful, of course!

If you give neurobics a try, let me know what you think! Or if you have other tips for staying mentally “fit,” please share them. I can be reached at npeditor@mdedge.com. And thank you to my friend Gail, who suggested this topic to me!

Every year, thousands of us vow to “get in shape” by eating right and exercising. (Whether we keep that resolution is another story.) But while we view physical exercise as a way to lose or maintain weight, reduce stress, or even hone athletic skills, we seldom think about exercising one of the most important muscles in our body: the brain.

“What?” you say. “The brain is not like other muscles.” No, it’s not … and yet, it isn’t as different as we used to think. Historically (maybe histologically?), it was believed that if nerve cells in the adult brain were damaged or had died, they, unlike other cells in the body, were not replaced. Longstanding scientific belief was that while the brain compensated for damage by making new connections to undamaged nerve cells, it could not regenerate because it does not contain stem cells.¹

But since the late 1990s, scientists have been debunking the negative myths about our brains as we age. They are not as static and unable to change as we have been led to fear! In fact, in 1998, American and Swedish scientists demonstrated that adult humans can generate new brain cells.^1,2 Moreover, the brain does replicate neurons in the hippocampus, the area in our brains that is central to learning and memory. Neurons continue to grow and change beyond the first years of development and well into adulthood.

So learning (and teaching) movements to encourage the rebuilding of our neurons is key to keeping our minds sharp. In his work, Ratey found that “our physical movements can directly influence our ability to learn, think, and remember.”³ He also tells us that exercise enhances circulation to the brain, “priming it for improved function, including mental health as well as cognitive ability.”⁴

No, you can’t put your brain on a treadmill to get, and help keep, it “in shape.” But you can do something to maintain mental sharpness and delay decline in mental agility. And these exercises don’t require a health club membership or special equipment. They can be done anytime, anywhere … and no one knows you are doing them!

I’m talking about neurobics, a term coined to describe exercises that keep us mentally fit.⁵ The purpose of these activities is to work our brains in nonroutine or unexpected ways, using all of our senses to experience, or re-experience, a common activity.

Not sure what that means? Here are some examples:

Spend time in a new environment. Go to a different park or a new store. Travel, by the way, seems to slow age-related mental decline.

Continue to: Smell new odors in the morning

Smell new odors in the morning. Have new scents, like a bottle of mint extract, ready to smell first thing in the morning, to “wake up” your brain.

Take a shower with your eyes closed. Other senses become more active when you cannot see, and a shower engages several.

Try brushing your teeth with your nondominant hand. This may be difficult for some of us—and it definitely requires full attention the first time you try it!

Learn to read braille. This is a tough one, but learning to read with your fingers definitely involves one of your senses in a new context. Or, you could try learning American Sign Language, which also uses your fingers to communicate.

Respond to a situation differently. Catch yourself in a normal, unconscious response to a situation, and choose to respond in an alternate (and preferably better) way.

Continue to: Find a new route to work

Find a new route to work. It doesn’t have to be longer, just different. You may even find a faster way to work once you break your routine.

Act confidently. In a situation you are unsure about, choose to act confidently. You’ll notice that your mind gets very active once you adopt the assumption that you will know what to do.

Distinguish coins using only your sense of touch. This brain exercise can be used to kill time while waiting for an appointment. If you really want a challenge, see if you can distinguish paper currency denominations by touch.

Leave the lights off in the house. Get around your home by memory and feel. This certainly fully engages your attention—but be careful, of course!

If you give neurobics a try, let me know what you think! Or if you have other tips for staying mentally “fit,” please share them. I can be reached at npeditor@mdedge.com. And thank you to my friend Gail, who suggested this topic to me!

Every year, thousands of us vow to “get in shape” by eating right and exercising. (Whether we keep that resolution is another story.) But while we view physical exercise as a way to lose or maintain weight, reduce stress, or even hone athletic skills, we seldom think about exercising one of the most important muscles in our body: the brain.

“What?” you say. “The brain is not like other muscles.” No, it’s not … and yet, it isn’t as different as we used to think. Historically (maybe histologically?), it was believed that if nerve cells in the adult brain were damaged or had died, they, unlike other cells in the body, were not replaced. Longstanding scientific belief was that while the brain compensated for damage by making new connections to undamaged nerve cells, it could not regenerate because it does not contain stem cells.¹

But since the late 1990s, scientists have been debunking the negative myths about our brains as we age. They are not as static and unable to change as we have been led to fear! In fact, in 1998, American and Swedish scientists demonstrated that adult humans can generate new brain cells.^1,2 Moreover, the brain does replicate neurons in the hippocampus, the area in our brains that is central to learning and memory. Neurons continue to grow and change beyond the first years of development and well into adulthood.

So learning (and teaching) movements to encourage the rebuilding of our neurons is key to keeping our minds sharp. In his work, Ratey found that “our physical movements can directly influence our ability to learn, think, and remember.”³ He also tells us that exercise enhances circulation to the brain, “priming it for improved function, including mental health as well as cognitive ability.”⁴

No, you can’t put your brain on a treadmill to get, and help keep, it “in shape.” But you can do something to maintain mental sharpness and delay decline in mental agility. And these exercises don’t require a health club membership or special equipment. They can be done anytime, anywhere … and no one knows you are doing them!

I’m talking about neurobics, a term coined to describe exercises that keep us mentally fit.⁵ The purpose of these activities is to work our brains in nonroutine or unexpected ways, using all of our senses to experience, or re-experience, a common activity.

Not sure what that means? Here are some examples:

Spend time in a new environment. Go to a different park or a new store. Travel, by the way, seems to slow age-related mental decline.

Continue to: Smell new odors in the morning

Smell new odors in the morning. Have new scents, like a bottle of mint extract, ready to smell first thing in the morning, to “wake up” your brain.

Take a shower with your eyes closed. Other senses become more active when you cannot see, and a shower engages several.

Try brushing your teeth with your nondominant hand. This may be difficult for some of us—and it definitely requires full attention the first time you try it!

Learn to read braille. This is a tough one, but learning to read with your fingers definitely involves one of your senses in a new context. Or, you could try learning American Sign Language, which also uses your fingers to communicate.

Respond to a situation differently. Catch yourself in a normal, unconscious response to a situation, and choose to respond in an alternate (and preferably better) way.

Continue to: Find a new route to work

Find a new route to work. It doesn’t have to be longer, just different. You may even find a faster way to work once you break your routine.

Act confidently. In a situation you are unsure about, choose to act confidently. You’ll notice that your mind gets very active once you adopt the assumption that you will know what to do.

Distinguish coins using only your sense of touch. This brain exercise can be used to kill time while waiting for an appointment. If you really want a challenge, see if you can distinguish paper currency denominations by touch.

Leave the lights off in the house. Get around your home by memory and feel. This certainly fully engages your attention—but be careful, of course!

If you give neurobics a try, let me know what you think! Or if you have other tips for staying mentally “fit,” please share them. I can be reached at npeditor@mdedge.com. And thank you to my friend Gail, who suggested this topic to me!

Vice Admiral Jerome M. Adams, MD, MPH, is the 20th Surgeon General of the United States, a post created in 1871.

Dr. Adams holds degrees in biochemistry and psychology from the University of Maryland, Baltimore County; a master’s degree in public health from the University of California, Berkeley; and a medical degree from the Indiana University, Indianapolis. He is a board-certified anesthesiologist and associate clinical professor of anesthesia at Indiana University.

At the 2018 Executive Advisory Board meeting of the Doctors Company, Richard E. Anderson, MD, FACP, chairman and chief executive officer of the Doctors Company, spoke with Dr. Adams about the opioid epidemic’s enormous impact on communities and health services in the United States.

Dr. Anderson: Dr. Adams, you’ve been busy since taking over as Surgeon General of the United States. What are some of the key challenges that you’re facing in this office?

Dr. Adams: You know, there are many challenges facing our country, but it boils down to a lack of wellness. We know that only 10% of health is due to health care, 20% of health is genetics, and the rest is a combination of behavior and environment.

My motto is “better health through better partnerships,” because I firmly believe that if we break out of our silos and reach across the traditional barriers that have been put up by funding, by reimbursement, and by infrastructure, then we can ultimately achieve wellness in our communities.

You asked what I’ve been focused on as Surgeon General. Well, I’m focused on three main areas right now.

No. 1 is the opioid epidemic. It is a scourge across our country. A person dies every 12½ minutes from an opioid overdose and that’s far too many. Especially when we know that many of those deaths can be prevented.

Another area I’m focused on is demonstrating the link between community health and economic prosperity. We want folks to invest in health because we know that not only will it achieve better health for individuals and communities but it will create a more prosperous nation, also.

And finally, I’m raising awareness about the links between our nation’s health and our safety and security – particularly our national security. Unfortunately, 7 out of 10 young people between the ages of 18 and 24 years old in our country are ineligible for military service. That’s because they can’t pass the physical, they can’t meet the educational requirements, or they have a criminal record.

So, our nation’s poor health is not just a matter of diabetes or heart disease 20 or 30 years down the road. We are literally a less-safe country right now because we’re an unhealthy country.
 

Dr. Anderson: Regarding the opioid epidemic, what are some of the programs that are available today that you find effective? What would you like to see us do as a nation to respond to the epidemic?

Dr. Adams: Recently, I was at a hospital in Alaska where they have implemented a neonatal abstinence syndrome protocol and program that is being looked at around the country – and others are attempting to replicate it.

We know that if you keep mom and baby together, baby does better, mom does better, hospital stays are shorter, costs go down, and you’re keeping that family unit intact. This prevents future problems for both the baby and the mother. That’s just one small example.

I’m also very happy to see that the prescribing of opioids is going down 20%-25% across the country. And there are even larger decreases in the military and veteran communities. That’s really a testament to doctors and the medical profession finally waking up. And I say this as a physician myself, as an anesthesiologist, as someone who is involved in acute and chronic pain management.

Four out of five people with substance use disorder say they started with a prescription opioid. Many physicians will say, “Those aren’t my patients,” but unfortunately when we look at the PDMP [prescription drug monitoring program] data across the country we do a poor job of predicting who is and who isn’t going to divert. It may not be your patient, but it could be their son or the babysitter who is diverting those overprescribed opioids.

One thing that I really think we need to lean into as health care practitioners is providing medication-assisted treatment, or MAT. We know that the gold standard for treatment and recovery is medication-assisted treatment of some form. But we also know it’s not nearly available enough and that there are barriers on the federal and state levels.

We need you to continue to talk to your congressional representatives and let them know which barriers you perceive because the data waiver comes directly from Congress.

Still, any ER can prescribe up to 3 days of MAT to someone. I’d much rather have our ER doctors putting patients on MAT and then connecting them to treatment, than sending them back out into the arms of a drug dealer after they put them into acute withdrawal with naloxone.

We also have too many pregnant women who want help but can’t find any treatment because no one out there will take care of pregnant moms. We need folks to step up to the plate and get that data waiver in our ob/gyn and primary care sectors.

Ultimately, we need hospitals and health care leaders to create an environment that makes providers feel comfortable providing that service by giving them the training and the support to be able to do it.

We also need to make sure we’re co-prescribing naloxone for those who are at risk for opioid overdose.
 

Dr. Anderson: Just so we are clear, are you in favor of regular prescribing of naloxone, along with prescriptions for opioids? Is that correct?

Dr. Adams: I issued the first Surgeon General’s advisory from more than 10 years earlier this year to help folks understand that over half of our opioid overdoses occur in a home setting. We all know that an anoxic brain injury occurs in 4-5 minutes. We also know that most ambulances and first responders aren’t going to show up in 4-5 minutes.

If we want to make a dent in this overdose epidemic, we need everyone to consider themselves a first responder. We need to look at it the same as we look at CPR; we need everyone carrying naloxone. That was one of the big pushes from my Surgeon General’s advisory.

How can providers help? Well, they can coprescribe naloxone to folks on high morphine milligram equivalents (MME) who are at risk. If grandma has naloxone at home and her grandson overdoses in the garage, then at least it’s in the same house. Naloxone is not the treatment for the opioid epidemic. But we can’t get someone who is dead into treatment.

I have no illusions that simply making naloxone available is going to turn the tide, but it certainly is an important part of it.
 

Dr. Anderson: From your unique viewpoint, how much progress do you see in relation to the opioid epidemic? Do you think we’re approaching an inflection point, or do you think there’s a long way to go before this starts to turn around?

Dr. Adams: When I talk about the opioid epidemic, I have two angles. No.1, I want to raise awareness about the opioid epidemic – the severity of it, and how everyone can lean into it in their own way. Whether it’s community citizens, providers, law enforcement, the business community, whomever.

But in addition to raising awareness, I want to instill hope.

I was in Huntington, West Virginia, just a few weeks ago at the epicenter of the opioid epidemic. They’ve been able to turn their opioid overdose rates around by providing peer recovery coaches to individuals and making sure naloxone is available throughout the community. You save the life and then you connect them to care.

We know that the folks who are at highest risk for overdose deaths are the ones who just overdosed. They come out of the ER where we’ve watched them for a few hours and then we send them right back out into the arms of the drug dealer to do exactly what we know they will do medically because we’ve thrown them into withdrawal and they try to get their next fix.

If we can partner with law enforcement, then we can turn our opioid overdose rates around.

A story of recovery that I want to share with you is about a guy named Jonathan, who I met when I was in Rhode Island.

Jonathan overdosed, but his roommate had access to naloxone, which he administered. Jonathan was taken to the ER and then connected with a peer recovery coach. He is now in recovery and has actually become a peer recovery coach himself. Saving this one life will now enable us to save many more.

Yet we still prescribe more than 80% of the world’s opioids to less than 5% of the world’s population. So, we still have an overprescribing epidemic, but we’ve surpassed the inflection point there. Prescribing is coming down.

But another part of this epidemic was that we squeezed the balloon in one place and, as prescribing opioids went down, lots of people switched over to heroin. That’s when we really first started to see overdose rates go up.

Well, it’s important for folks to know that, through law enforcement, through partnerships with the public health community, through an increase in syringe service programs, and through other touch points, heroin use is now going down in most places.

Unfortunately, now we’re seeing the third wave of the epidemic, and that’s fentanyl and carfentanil.






 

Vice Admiral Jerome M. Adams, MD, MPH, is the 20th Surgeon General of the United States, a post created in 1871.

Dr. Adams holds degrees in biochemistry and psychology from the University of Maryland, Baltimore County; a master’s degree in public health from the University of California, Berkeley; and a medical degree from the Indiana University, Indianapolis. He is a board-certified anesthesiologist and associate clinical professor of anesthesia at Indiana University.

At the 2018 Executive Advisory Board meeting of the Doctors Company, Richard E. Anderson, MD, FACP, chairman and chief executive officer of the Doctors Company, spoke with Dr. Adams about the opioid epidemic’s enormous impact on communities and health services in the United States.

Dr. Anderson: Dr. Adams, you’ve been busy since taking over as Surgeon General of the United States. What are some of the key challenges that you’re facing in this office?

Dr. Adams: You know, there are many challenges facing our country, but it boils down to a lack of wellness. We know that only 10% of health is due to health care, 20% of health is genetics, and the rest is a combination of behavior and environment.

My motto is “better health through better partnerships,” because I firmly believe that if we break out of our silos and reach across the traditional barriers that have been put up by funding, by reimbursement, and by infrastructure, then we can ultimately achieve wellness in our communities.

You asked what I’ve been focused on as Surgeon General. Well, I’m focused on three main areas right now.

No. 1 is the opioid epidemic. It is a scourge across our country. A person dies every 12½ minutes from an opioid overdose and that’s far too many. Especially when we know that many of those deaths can be prevented.

Another area I’m focused on is demonstrating the link between community health and economic prosperity. We want folks to invest in health because we know that not only will it achieve better health for individuals and communities but it will create a more prosperous nation, also.

And finally, I’m raising awareness about the links between our nation’s health and our safety and security – particularly our national security. Unfortunately, 7 out of 10 young people between the ages of 18 and 24 years old in our country are ineligible for military service. That’s because they can’t pass the physical, they can’t meet the educational requirements, or they have a criminal record.

So, our nation’s poor health is not just a matter of diabetes or heart disease 20 or 30 years down the road. We are literally a less-safe country right now because we’re an unhealthy country.
 

Dr. Anderson: Regarding the opioid epidemic, what are some of the programs that are available today that you find effective? What would you like to see us do as a nation to respond to the epidemic?

Dr. Adams: Recently, I was at a hospital in Alaska where they have implemented a neonatal abstinence syndrome protocol and program that is being looked at around the country – and others are attempting to replicate it.

We know that if you keep mom and baby together, baby does better, mom does better, hospital stays are shorter, costs go down, and you’re keeping that family unit intact. This prevents future problems for both the baby and the mother. That’s just one small example.

I’m also very happy to see that the prescribing of opioids is going down 20%-25% across the country. And there are even larger decreases in the military and veteran communities. That’s really a testament to doctors and the medical profession finally waking up. And I say this as a physician myself, as an anesthesiologist, as someone who is involved in acute and chronic pain management.

Four out of five people with substance use disorder say they started with a prescription opioid. Many physicians will say, “Those aren’t my patients,” but unfortunately when we look at the PDMP [prescription drug monitoring program] data across the country we do a poor job of predicting who is and who isn’t going to divert. It may not be your patient, but it could be their son or the babysitter who is diverting those overprescribed opioids.

One thing that I really think we need to lean into as health care practitioners is providing medication-assisted treatment, or MAT. We know that the gold standard for treatment and recovery is medication-assisted treatment of some form. But we also know it’s not nearly available enough and that there are barriers on the federal and state levels.

We need you to continue to talk to your congressional representatives and let them know which barriers you perceive because the data waiver comes directly from Congress.

Still, any ER can prescribe up to 3 days of MAT to someone. I’d much rather have our ER doctors putting patients on MAT and then connecting them to treatment, than sending them back out into the arms of a drug dealer after they put them into acute withdrawal with naloxone.

We also have too many pregnant women who want help but can’t find any treatment because no one out there will take care of pregnant moms. We need folks to step up to the plate and get that data waiver in our ob/gyn and primary care sectors.

Ultimately, we need hospitals and health care leaders to create an environment that makes providers feel comfortable providing that service by giving them the training and the support to be able to do it.

We also need to make sure we’re co-prescribing naloxone for those who are at risk for opioid overdose.
 

Dr. Anderson: Just so we are clear, are you in favor of regular prescribing of naloxone, along with prescriptions for opioids? Is that correct?

Dr. Adams: I issued the first Surgeon General’s advisory from more than 10 years earlier this year to help folks understand that over half of our opioid overdoses occur in a home setting. We all know that an anoxic brain injury occurs in 4-5 minutes. We also know that most ambulances and first responders aren’t going to show up in 4-5 minutes.

If we want to make a dent in this overdose epidemic, we need everyone to consider themselves a first responder. We need to look at it the same as we look at CPR; we need everyone carrying naloxone. That was one of the big pushes from my Surgeon General’s advisory.

How can providers help? Well, they can coprescribe naloxone to folks on high morphine milligram equivalents (MME) who are at risk. If grandma has naloxone at home and her grandson overdoses in the garage, then at least it’s in the same house. Naloxone is not the treatment for the opioid epidemic. But we can’t get someone who is dead into treatment.

I have no illusions that simply making naloxone available is going to turn the tide, but it certainly is an important part of it.
 

Dr. Anderson: From your unique viewpoint, how much progress do you see in relation to the opioid epidemic? Do you think we’re approaching an inflection point, or do you think there’s a long way to go before this starts to turn around?

Dr. Adams: When I talk about the opioid epidemic, I have two angles. No.1, I want to raise awareness about the opioid epidemic – the severity of it, and how everyone can lean into it in their own way. Whether it’s community citizens, providers, law enforcement, the business community, whomever.

But in addition to raising awareness, I want to instill hope.

I was in Huntington, West Virginia, just a few weeks ago at the epicenter of the opioid epidemic. They’ve been able to turn their opioid overdose rates around by providing peer recovery coaches to individuals and making sure naloxone is available throughout the community. You save the life and then you connect them to care.

We know that the folks who are at highest risk for overdose deaths are the ones who just overdosed. They come out of the ER where we’ve watched them for a few hours and then we send them right back out into the arms of the drug dealer to do exactly what we know they will do medically because we’ve thrown them into withdrawal and they try to get their next fix.

If we can partner with law enforcement, then we can turn our opioid overdose rates around.

A story of recovery that I want to share with you is about a guy named Jonathan, who I met when I was in Rhode Island.

Jonathan overdosed, but his roommate had access to naloxone, which he administered. Jonathan was taken to the ER and then connected with a peer recovery coach. He is now in recovery and has actually become a peer recovery coach himself. Saving this one life will now enable us to save many more.

Yet we still prescribe more than 80% of the world’s opioids to less than 5% of the world’s population. So, we still have an overprescribing epidemic, but we’ve surpassed the inflection point there. Prescribing is coming down.

But another part of this epidemic was that we squeezed the balloon in one place and, as prescribing opioids went down, lots of people switched over to heroin. That’s when we really first started to see overdose rates go up.

Well, it’s important for folks to know that, through law enforcement, through partnerships with the public health community, through an increase in syringe service programs, and through other touch points, heroin use is now going down in most places.

Unfortunately, now we’re seeing the third wave of the epidemic, and that’s fentanyl and carfentanil.






 

Vice Admiral Jerome M. Adams, MD, MPH, is the 20th Surgeon General of the United States, a post created in 1871.

Dr. Adams holds degrees in biochemistry and psychology from the University of Maryland, Baltimore County; a master’s degree in public health from the University of California, Berkeley; and a medical degree from the Indiana University, Indianapolis. He is a board-certified anesthesiologist and associate clinical professor of anesthesia at Indiana University.

At the 2018 Executive Advisory Board meeting of the Doctors Company, Richard E. Anderson, MD, FACP, chairman and chief executive officer of the Doctors Company, spoke with Dr. Adams about the opioid epidemic’s enormous impact on communities and health services in the United States.

Dr. Anderson: Dr. Adams, you’ve been busy since taking over as Surgeon General of the United States. What are some of the key challenges that you’re facing in this office?

Dr. Adams: You know, there are many challenges facing our country, but it boils down to a lack of wellness. We know that only 10% of health is due to health care, 20% of health is genetics, and the rest is a combination of behavior and environment.

My motto is “better health through better partnerships,” because I firmly believe that if we break out of our silos and reach across the traditional barriers that have been put up by funding, by reimbursement, and by infrastructure, then we can ultimately achieve wellness in our communities.

You asked what I’ve been focused on as Surgeon General. Well, I’m focused on three main areas right now.

No. 1 is the opioid epidemic. It is a scourge across our country. A person dies every 12½ minutes from an opioid overdose and that’s far too many. Especially when we know that many of those deaths can be prevented.

Another area I’m focused on is demonstrating the link between community health and economic prosperity. We want folks to invest in health because we know that not only will it achieve better health for individuals and communities but it will create a more prosperous nation, also.

And finally, I’m raising awareness about the links between our nation’s health and our safety and security – particularly our national security. Unfortunately, 7 out of 10 young people between the ages of 18 and 24 years old in our country are ineligible for military service. That’s because they can’t pass the physical, they can’t meet the educational requirements, or they have a criminal record.

So, our nation’s poor health is not just a matter of diabetes or heart disease 20 or 30 years down the road. We are literally a less-safe country right now because we’re an unhealthy country.
 

Dr. Anderson: Regarding the opioid epidemic, what are some of the programs that are available today that you find effective? What would you like to see us do as a nation to respond to the epidemic?

Dr. Adams: Recently, I was at a hospital in Alaska where they have implemented a neonatal abstinence syndrome protocol and program that is being looked at around the country – and others are attempting to replicate it.

We know that if you keep mom and baby together, baby does better, mom does better, hospital stays are shorter, costs go down, and you’re keeping that family unit intact. This prevents future problems for both the baby and the mother. That’s just one small example.

I’m also very happy to see that the prescribing of opioids is going down 20%-25% across the country. And there are even larger decreases in the military and veteran communities. That’s really a testament to doctors and the medical profession finally waking up. And I say this as a physician myself, as an anesthesiologist, as someone who is involved in acute and chronic pain management.

Four out of five people with substance use disorder say they started with a prescription opioid. Many physicians will say, “Those aren’t my patients,” but unfortunately when we look at the PDMP [prescription drug monitoring program] data across the country we do a poor job of predicting who is and who isn’t going to divert. It may not be your patient, but it could be their son or the babysitter who is diverting those overprescribed opioids.

One thing that I really think we need to lean into as health care practitioners is providing medication-assisted treatment, or MAT. We know that the gold standard for treatment and recovery is medication-assisted treatment of some form. But we also know it’s not nearly available enough and that there are barriers on the federal and state levels.

We need you to continue to talk to your congressional representatives and let them know which barriers you perceive because the data waiver comes directly from Congress.

Still, any ER can prescribe up to 3 days of MAT to someone. I’d much rather have our ER doctors putting patients on MAT and then connecting them to treatment, than sending them back out into the arms of a drug dealer after they put them into acute withdrawal with naloxone.

We also have too many pregnant women who want help but can’t find any treatment because no one out there will take care of pregnant moms. We need folks to step up to the plate and get that data waiver in our ob/gyn and primary care sectors.

Ultimately, we need hospitals and health care leaders to create an environment that makes providers feel comfortable providing that service by giving them the training and the support to be able to do it.

We also need to make sure we’re co-prescribing naloxone for those who are at risk for opioid overdose.
 

Dr. Anderson: Just so we are clear, are you in favor of regular prescribing of naloxone, along with prescriptions for opioids? Is that correct?

Dr. Adams: I issued the first Surgeon General’s advisory from more than 10 years earlier this year to help folks understand that over half of our opioid overdoses occur in a home setting. We all know that an anoxic brain injury occurs in 4-5 minutes. We also know that most ambulances and first responders aren’t going to show up in 4-5 minutes.

If we want to make a dent in this overdose epidemic, we need everyone to consider themselves a first responder. We need to look at it the same as we look at CPR; we need everyone carrying naloxone. That was one of the big pushes from my Surgeon General’s advisory.

How can providers help? Well, they can coprescribe naloxone to folks on high morphine milligram equivalents (MME) who are at risk. If grandma has naloxone at home and her grandson overdoses in the garage, then at least it’s in the same house. Naloxone is not the treatment for the opioid epidemic. But we can’t get someone who is dead into treatment.

I have no illusions that simply making naloxone available is going to turn the tide, but it certainly is an important part of it.
 

Dr. Anderson: From your unique viewpoint, how much progress do you see in relation to the opioid epidemic? Do you think we’re approaching an inflection point, or do you think there’s a long way to go before this starts to turn around?

Dr. Adams: When I talk about the opioid epidemic, I have two angles. No.1, I want to raise awareness about the opioid epidemic – the severity of it, and how everyone can lean into it in their own way. Whether it’s community citizens, providers, law enforcement, the business community, whomever.

But in addition to raising awareness, I want to instill hope.

I was in Huntington, West Virginia, just a few weeks ago at the epicenter of the opioid epidemic. They’ve been able to turn their opioid overdose rates around by providing peer recovery coaches to individuals and making sure naloxone is available throughout the community. You save the life and then you connect them to care.

We know that the folks who are at highest risk for overdose deaths are the ones who just overdosed. They come out of the ER where we’ve watched them for a few hours and then we send them right back out into the arms of the drug dealer to do exactly what we know they will do medically because we’ve thrown them into withdrawal and they try to get their next fix.

If we can partner with law enforcement, then we can turn our opioid overdose rates around.

A story of recovery that I want to share with you is about a guy named Jonathan, who I met when I was in Rhode Island.

Jonathan overdosed, but his roommate had access to naloxone, which he administered. Jonathan was taken to the ER and then connected with a peer recovery coach. He is now in recovery and has actually become a peer recovery coach himself. Saving this one life will now enable us to save many more.

Yet we still prescribe more than 80% of the world’s opioids to less than 5% of the world’s population. So, we still have an overprescribing epidemic, but we’ve surpassed the inflection point there. Prescribing is coming down.

But another part of this epidemic was that we squeezed the balloon in one place and, as prescribing opioids went down, lots of people switched over to heroin. That’s when we really first started to see overdose rates go up.

Well, it’s important for folks to know that, through law enforcement, through partnerships with the public health community, through an increase in syringe service programs, and through other touch points, heroin use is now going down in most places.

Unfortunately, now we’re seeing the third wave of the epidemic, and that’s fentanyl and carfentanil.